Pharmacos Exakta, S.A. De C.V.
⚠️ Moderate Risk
FEI: 3006449010 • Zapopan, Jalisco • MEXICO
FEI Number
3006449010
Location
Zapopan, Jalisco
Country
MEXICOAddress
Avenida Nino Obrero 651, Col. Ciudad Del Sol, Zapopan, Zapopan, Jalisco, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/22/2022 | 56DDK40NEOMYCIN (AMINOGLYCOSIDES) | Division of Southeast Imports (DSEI) | |
| 3/10/2022 | 56DDK40NEOMYCIN (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2020 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Pharmacos Exakta, S.A. De C.V.'s FDA import refusal history?
Pharmacos Exakta, S.A. De C.V. (FEI: 3006449010) has 3 FDA import refusal record(s) in our database, spanning from 1/31/2020 to 9/22/2022.
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. Pharmacos Exakta, S.A. De C.V.'s FEI number is 3006449010.
What types of violations has Pharmacos Exakta, S.A. De C.V. received?
Pharmacos Exakta, 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 Pharmacos Exakta, S.A. De C.V. come from?
All FDA import refusal data for Pharmacos Exakta, 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.