Vikas Laboratories Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3010165928 • Navi Mumbai, Maharashtra • INDIA
FEI Number
3010165928
Location
Navi Mumbai, Maharashtra
Country
INDIAAddress
Plot R/891, Ttc Industrial, Navi Mumbai, Maharashtra, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
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).
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.
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.
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.
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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 |
|---|---|---|---|
| 3/6/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | New Orleans District Office (NOL-DO) | |
| 2/5/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | New Orleans District Office (NOL-DO) | |
| 2/5/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | New Orleans District Office (NOL-DO) | |
| 2/5/2013 | 64ABY20TRICLOSAN (DISINFECTANT) | New Orleans District Office (NOL-DO) | |
| 2/5/2013 | 64ABY20TRICLOSAN (DISINFECTANT) | New Orleans District Office (NOL-DO) | |
| 2/5/2013 | 64ABY20TRICLOSAN (DISINFECTANT) | New Orleans District Office (NOL-DO) | |
| 1/2/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/30/2008 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 310POISONOUS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Vikas Laboratories Pvt. Ltd.'s FDA import refusal history?
Vikas Laboratories Pvt. Ltd. (FEI: 3010165928) has 16 FDA import refusal record(s) in our database, spanning from 6/30/2008 to 3/6/2013.
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. Vikas Laboratories Pvt. Ltd.'s FEI number is 3010165928.
What types of violations has Vikas Laboratories Pvt. Ltd. received?
Vikas Laboratories Pvt. Ltd. has been cited for 6 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 Vikas Laboratories Pvt. Ltd. come from?
All FDA import refusal data for Vikas Laboratories Pvt. Ltd. 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.