Convatec/Bristal Meyers/Squibb
⚠️ Moderate Risk
FEI: 3003245438 • Princeton, NJ • UNITED STATES
FEI Number
3003245438
Location
Princeton, NJ
Country
UNITED STATESAddress
PO Box 5254, , Princeton, NJ, United States
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/13/2003 | 66VBZ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/20/2001 | 78FONBAG, DRAINAGE, WITH ADHESIVE, OSTOMY | Cincinnati District Office (CIN-DO) | |
| 10/20/2001 | 78EZRCEMENT, STOMAL APPLIANCE, OSTOMY | Cincinnati District Office (CIN-DO) | |
| 10/20/2001 | 78LNTADHESIVE, TISSUE FOR GASTRO-UROLOGY USE | Cincinnati District Office (CIN-DO) | |
| 10/8/2001 | 78EZQPOUCH, COLOSTOMY | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Convatec/Bristal Meyers/Squibb's FDA import refusal history?
Convatec/Bristal Meyers/Squibb (FEI: 3003245438) has 5 FDA import refusal record(s) in our database, spanning from 10/8/2001 to 5/13/2003.
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. Convatec/Bristal Meyers/Squibb's FEI number is 3003245438.
What types of violations has Convatec/Bristal Meyers/Squibb received?
Convatec/Bristal Meyers/Squibb 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 Convatec/Bristal Meyers/Squibb come from?
All FDA import refusal data for Convatec/Bristal Meyers/Squibb 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.