LABORATORIOS PISA S.A DE C.V.
⚠️ High Risk
FEI: 3021685802 • Cuidad De Mexic • MEXICO
FEI Number
3021685802
Location
Cuidad De Mexic
Country
MEXICOAddress
No. 555 Col Romero De T, , Cuidad De Mexic, , 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/28/2023 | 62GCA94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/3/2023 | 56JDC21CLINDAMYCIN PALMITATE HYDROCHLORIDE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2023 | 64LCB56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2023 | 61NCH69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2023 | 62OCY37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2022 | 60LBA01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) |
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: 3021685802) has 7 FDA import refusal record(s) in our database, spanning from 10/17/2022 to 11/28/2023.
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 3021685802.
What types of violations has LABORATORIOS PISA S.A DE C.V. received?
LABORATORIOS PISA S.A DE C.V. has been cited for 2 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.