Laboratorios Bremer, S.A.
⚠️ Moderate Risk
FEI: 3003097030 • Garcia, Nuevo Leon • MEXICO
FEI Number
3003097030
Location
Garcia, Nuevo Leon
Country
MEXICOAddress
Cd Industrial Mitras, Omicron 8116; Garcia, Garcia, Nuevo Leon, 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).
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2018 | 60LBJ99ANALGESIC, N.E.C. | Division of Southwest Imports (DSWI) | |
| 8/21/2013 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/8/2013 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 11/14/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 7/18/2011 | 53LG08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 3/10/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 8/20/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
| 12/28/2001 | 60LBJ63SALICYLAMIDE (ANALGESIC) | Southwest Import District Office (SWI-DO) | |
| 12/12/2001 | 60LBJ63SALICYLAMIDE (ANALGESIC) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratorios Bremer, S.A.'s FDA import refusal history?
Laboratorios Bremer, S.A. (FEI: 3003097030) has 9 FDA import refusal record(s) in our database, spanning from 12/12/2001 to 3/28/2018.
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. Laboratorios Bremer, S.A.'s FEI number is 3003097030.
What types of violations has Laboratorios Bremer, S.A. received?
Laboratorios Bremer, S.A. has been cited for 10 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 Laboratorios Bremer, S.A. come from?
All FDA import refusal data for Laboratorios Bremer, 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.