Casa Granado Laboratorios, Farmacias e Drogarias S/A

⚠️ Moderate Risk

FEI: 3014479386 • Rio De Janeiro • BRAZIL

FEI

FEI Number

3014479386

📍

Location

Rio De Janeiro

🇧🇷

Country

BRAZIL

🏢

Address

Avenida Presidente Tancredo Neves, N 30, Jardim Marajoara, Japeri, Rio De Janeiro, , Brazil

Moderate Risk

FDA Import Risk Assessment

39.9

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/30/2021

Latest Refusal

11/4/2004

Earliest Refusal

Score Breakdown

Violation Severity

68.2×40%

Refusal Volume

40.0×30%

Recency

0.0×20%

Frequency

6.5×10%

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

758×

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).

1187×

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).

1973×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

4712×

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.

4741×

COSMETLBLG

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

4751×

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.

Refusal History

Date	Product	Violations	Division
8/30/2021	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	197COSM COLOR 471CSTIC LBLG 474COSMETLBLG 475COSMETLBLG	Division of Northeast Imports (DNEI)
8/30/2021	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	197COSM COLOR 471CSTIC LBLG	Division of Northeast Imports (DNEI)
8/30/2021	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	197COSM COLOR	Division of Northeast Imports (DNEI)
6/6/2013	53LH04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS)	75UNAPPROVED	Southwest Import District Office (SWI-DO)
11/4/2004	62WAZ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2004	62WAZ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2004	62WAZ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2004	62WAZ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2004	62WAZ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2004	62WAZ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2004	62WAZ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Casa Granado Laboratorios, Farmacias e Drogarias S/A's FDA import refusal history?

Casa Granado Laboratorios, Farmacias e Drogarias S/A (FEI: 3014479386) has 11 FDA import refusal record(s) in our database, spanning from 11/4/2004 to 8/30/2021.

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. Casa Granado Laboratorios, Farmacias e Drogarias S/A's FEI number is 3014479386.

What types of violations has Casa Granado Laboratorios, Farmacias e Drogarias S/A received?

Casa Granado Laboratorios, Farmacias e Drogarias S/A 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 Casa Granado Laboratorios, Farmacias e Drogarias S/A come from?

All FDA import refusal data for Casa Granado Laboratorios, Farmacias e Drogarias S/A 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.