KALINA

⚠️ Moderate Risk

FEI: 3011485210 • Yekaterinburg, Sverdlovskaya obl • RUSSIA

FEI

FEI Number

3011485210

📍

Location

Yekaterinburg, Sverdlovskaya obl

🇷🇺

Country

RUSSIA

🏢

Address

Ul. Komsomolskaya 80, , Yekaterinburg, Sverdlovskaya obl, Russia

Moderate Risk

FDA Import Risk Assessment

49.1

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

117

Total Refusals

Unique Violations

1/16/2018

Latest Refusal

8/28/2012

Earliest Refusal

Score Breakdown

Violation Severity

40.2×40%

Refusal Volume

76.7×30%

Recency

0.0×20%

Frequency

100.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

473114×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

474105×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

471104×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

475104×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

1186×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32805×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

3335×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

4725×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

3354×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

Date	Product	Violations	Division
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/16/2018	53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53LC06MOISTURIZING (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53LC06MOISTURIZING (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53LC06MOISTURIZING (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53LC06MOISTURIZING (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/12/2018	53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING 474COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
1/5/2018	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
12/18/2017	53LC06MOISTURIZING (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
12/18/2017	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
12/18/2017	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
12/18/2017	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
12/18/2017	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
12/18/2017	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
12/18/2017	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
12/18/2017	53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
11/9/2017	53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
11/9/2017	53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
11/9/2017	53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
11/9/2017	53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
11/9/2017	53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)
11/9/2017	53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)	471CSTIC LBLG 473LABELING 474COSMETLBLG 475COSMETLBLG	Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is KALINA's FDA import refusal history?

KALINA (FEI: 3011485210) has 117 FDA import refusal record(s) in our database, spanning from 8/28/2012 to 1/16/2018.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. KALINA's FEI number is 3011485210.

What types of violations has KALINA received?

KALINA has been cited for 12 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about KALINA come from?

All FDA import refusal data for KALINA is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.