Bqm Laboratorios, S.A De C.V.
⚠️ High Risk
FEI: 3003177007 • Zapopan, Jalisco • MEXICO
FEI Number
3003177007
Location
Zapopan, Jalisco
Country
MEXICOAddress
Ave El Colli No. 4805, , Zapopan, Jalisco, Mexico
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
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).
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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 |
|---|---|---|---|
| 3/10/2003 | 54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/10/2003 | 54FCK99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/18/2002 | 54BCL01CALCIUM (MINERAL) | 260FALSE | Southwest Import District Office (SWI-DO) |
| 12/18/2002 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/23/2002 | 54BCL01CALCIUM (MINERAL) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/23/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/7/2002 | 60LAJ99ANALGESIC, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/7/2002 | 60LBJ99ANALGESIC, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 5/7/2002 | 66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Bqm Laboratorios, S.A De C.V.'s FDA import refusal history?
Bqm Laboratorios, S.A De C.V. (FEI: 3003177007) has 9 FDA import refusal record(s) in our database, spanning from 5/7/2002 to 3/10/2003.
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. Bqm Laboratorios, S.A De C.V.'s FEI number is 3003177007.
What types of violations has Bqm Laboratorios, S.A De C.V. received?
Bqm Laboratorios, S.A De C.V. has been cited for 3 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 Bqm Laboratorios, S.A De C.V. come from?
All FDA import refusal data for Bqm Laboratorios, S.A 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.