Bristol - Myers Squibb De Mexico, S. De R.L. De C.V.
⚠️ Moderate Risk
FEI: 3003766669 • Mexico D.F. • MEXICO
FEI Number
3003766669
Location
Mexico D.F.
Country
MEXICOAddress
Calzada de Tlanpan no. 2996, Col. Ejido de Santa Ursula Coapa, Mexico D.F., , Mexico
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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/12/2017 | 65RBB18SODIUM BICARBONATE (REPLENISHER) | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 7/13/2016 | 65RBR18SODIUM BICARBONATE (REPLENISHER) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/20/2013 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/21/2012 | 60SBR99ANTACID, N.E.C. | Division of Southwest Imports (DSWI) | |
| 1/15/2008 | 56BDF07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bristol - Myers Squibb De Mexico, S. De R.L. De C.V.'s FDA import refusal history?
Bristol - Myers Squibb De Mexico, S. De R.L. De C.V. (FEI: 3003766669) has 5 FDA import refusal record(s) in our database, spanning from 1/15/2008 to 5/12/2017.
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. Bristol - Myers Squibb De Mexico, S. De R.L. De C.V.'s FEI number is 3003766669.
What types of violations has Bristol - Myers Squibb De Mexico, S. De R.L. De C.V. received?
Bristol - Myers Squibb De Mexico, S. De R.L. De C.V. has been cited for 5 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 Bristol - Myers Squibb De Mexico, S. De R.L. De C.V. come from?
All FDA import refusal data for Bristol - Myers Squibb De Mexico, S. De R.L. De C.V. 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.