Laboratorio Charlot, S.A.

⚠️ Moderate Risk

FEI: 3004120030 • Santo Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3004120030

📍

Location

Santo Domingo

🇩🇴

Country

DOMINICAN REPUBLIC

🏢

Address

C 2da. Esq. Elizabeth Bodden Urb., , Santo Domingo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

48.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/9/2005

Latest Refusal

8/9/2005

Earliest Refusal

Score Breakdown

Violation Severity

56.9×40%

Refusal Volume

53.0×30%

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

47125×

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.

19712×

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).

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

1981×

COLOR LBLG

The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.

Refusal History

Date	Product	Violations	Division
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
8/9/2005	53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	11UNSAFE COL 198COLOR LBLG	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Laboratorio Charlot, S.A.'s FDA import refusal history?

Laboratorio Charlot, S.A. (FEI: 3004120030) has 26 FDA import refusal record(s) in our database, spanning from 8/9/2005 to 8/9/2005.

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. Laboratorio Charlot, S.A.'s FEI number is 3004120030.

What types of violations has Laboratorio Charlot, S.A. received?

Laboratorio Charlot, S.A. has been cited for 4 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 Laboratorio Charlot, S.A. come from?

All FDA import refusal data for Laboratorio Charlot, 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.