Genomma Laboratories S.A. De C.V.
⚠️ Moderate Risk
FEI: 3006539056 • Mexico Df • MEXICO
FEI Number
3006539056
Location
Mexico Df
Country
MEXICOAddress
Ave. Paseo De La Reforma # 122, 3-Acol., , 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
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).
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).
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.
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2010 | 64XAU06SALICYLIC ACID (KERATOLYTIC) | Southwest Import District Office (SWI-DO) | |
| 12/9/2010 | 64XAU06SALICYLIC ACID (KERATOLYTIC) | Southwest Import District Office (SWI-DO) | |
| 12/9/2010 | 64XAU06SALICYLIC ACID (KERATOLYTIC) | Southwest Import District Office (SWI-DO) | |
| 12/9/2010 | 64XAU06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 10/8/2009 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 10/8/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 10/8/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/8/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/8/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/8/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/8/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/8/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Genomma Laboratories S.A. De C.V.'s FDA import refusal history?
Genomma Laboratories S.A. De C.V. (FEI: 3006539056) has 12 FDA import refusal record(s) in our database, spanning from 10/8/2009 to 12/9/2010.
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. Genomma Laboratories S.A. De C.V.'s FEI number is 3006539056.
What types of violations has Genomma Laboratories S.A. De C.V. received?
Genomma Laboratories S.A. 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 Genomma Laboratories S.A. De C.V. come from?
All FDA import refusal data for Genomma Laboratories 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.