Patcos Cosmetics (India) Private Limited
⚠️ High Risk
FEI: 3009250196 • Daman, Dadra And Nagar Haveli And Dam • INDIA
FEI Number
3009250196
Location
Daman, Dadra And Nagar Haveli And Dam
Country
INDIAAddress
659 Kevdi Falia Road, , Daman, Dadra And Nagar Haveli And Dam, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Patcos Cosmetics (India) Private Limited's FDA import refusal history?
Patcos Cosmetics (India) Private Limited (FEI: 3009250196) has 15 FDA import refusal record(s) in our database, spanning from 4/15/2024 to 4/15/2024.
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. Patcos Cosmetics (India) Private Limited's FEI number is 3009250196.
What types of violations has Patcos Cosmetics (India) Private Limited received?
Patcos Cosmetics (India) Private Limited has been cited for 1 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 Patcos Cosmetics (India) Private Limited come from?
All FDA import refusal data for Patcos Cosmetics (India) Private Limited 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.