Laboratorios Reomatolum, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3002780028 • Puebla, puebla • MEXICO
FEI Number
3002780028
Location
Puebla, puebla
Country
MEXICOAddress
27 Poniente No. 1705, , Puebla, puebla, 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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/10/2012 | 55QY19PETROLATUM (PHARMACEUTIC NECESSITY - OINTMENT BASE) | Southwest Import District Office (SWI-DO) | |
| 12/31/2002 | 60LBJ63SALICYLAMIDE (ANALGESIC) | 473LABELING | Southwest Import District Office (SWI-DO) |
| 8/20/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 7/30/2002 | 66VBE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/27/2001 | 63IBL02SILVER NITRATE (TOUGHENED) (CAUSTIC) | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 63IBL02SILVER NITRATE (TOUGHENED) (CAUSTIC) | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 61HIJ99ANTI-BACTERIAL, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 61HIJ99ANTI-BACTERIAL, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 61GIJ56SULFAMETHIZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 11/27/2001 | 60LBJ99ANALGESIC, N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Laboratorios Reomatolum, S.A. de C.V.'s FDA import refusal history?
Laboratorios Reomatolum, S.A. de C.V. (FEI: 3002780028) has 11 FDA import refusal record(s) in our database, spanning from 11/27/2001 to 5/10/2012.
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 Reomatolum, S.A. de C.V.'s FEI number is 3002780028.
What types of violations has Laboratorios Reomatolum, S.A. de C.V. received?
Laboratorios Reomatolum, S.A. de C.V. has been cited for 4 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 Reomatolum, S.A. de C.V. come from?
All FDA import refusal data for Laboratorios Reomatolum, 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.