Cetco S.A.
⚠️ Moderate Risk
FEI: 3001446132 • Lima • PERU
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | San Juan District Office (SJN-DO) | |
| 12/14/2004 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 12/13/2004 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 11/16/2004 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 10/18/2004 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 4/3/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 4/3/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 4/3/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Cetco S.A.'s FDA import refusal history?
Cetco S.A. (FEI: 3001446132) has 8 FDA import refusal record(s) in our database, spanning from 4/3/2003 to 12/13/2005.
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. Cetco S.A.'s FEI number is 3001446132.
What types of violations has Cetco S.A. received?
Cetco S.A. has been cited for 2 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 Cetco S.A. come from?
All FDA import refusal data for Cetco 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.