Bristol - Myers Squibb De Mexico, S. De R.L. De C.V.
⚠️ Moderate Risk
FEI: 3002895648 • Mexico Df • MEXICO
FEI Number
3002895648
Location
Mexico Df
Country
MEXICOAddress
Av. Revolucion 1267 Col. Tlacopac, Delegacion Alvaro Obregon, Mexico Df, , 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).
NO ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/22/2016 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/27/2007 | 56BCL07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/10/2006 | 34HET99CHOCOLATE AND COCOA BEVERAGE BASE, N.E.C. | 482NUTRIT LBL | Southwest Import District Office (SWI-DO) |
| 4/22/2005 | 31KGT04TEA, MIXED (GREEN AND BLACK, ETC.) | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 4/22/2005 | 31KGT04TEA, MIXED (GREEN AND BLACK, ETC.) | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 5/26/2004 | 41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/26/2004 | 41EMT99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/26/2003 | 56BCZ05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Chicago District Office (CHI-DO) | |
| 3/26/2003 | 56BCE05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Chicago District Office (CHI-DO) | |
| 10/22/2002 | 56BCE05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 10/22/2002 | 56BCE05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Chicago District Office (CHI-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: 3002895648) has 11 FDA import refusal record(s) in our database, spanning from 10/22/2002 to 3/22/2016.
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 3002895648.
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.