Laboratorios Pisa S.A de C.V
⚠️ High Risk
FEI: 3005486766 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3005486766
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Avenida Miguel Angel De Quevedo No. 555, Col. Romero De Terreros, Coyoacan, Ciudad De Mexico, Ciudad de Mexico, 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).
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/14/2025 | 60SQY21CISAPRIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2025 | 66JCY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | Division of Southeast Imports (DSEI) | |
| 8/27/2024 | 62TDY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2023 | 62TCC07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2022 | 60LAA01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 8/20/2021 | 62VDA18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2020 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/14/2019 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2016 | 64LCY99GLUCOCORTICOID N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/15/2016 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/16/2015 | 62GDA86ALLOPURINOL SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/7/2007 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Laboratorios Pisa S.A de C.V's FDA import refusal history?
Laboratorios Pisa S.A de C.V (FEI: 3005486766) has 12 FDA import refusal record(s) in our database, spanning from 5/7/2007 to 10/14/2025.
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 Pisa S.A de C.V's FEI number is 3005486766.
What types of violations has Laboratorios Pisa S.A de C.V received?
Laboratorios Pisa 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 Pisa S.A de C.V come from?
All FDA import refusal data for Laboratorios Pisa 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.