PISA SA DE CV
⚠️ High Risk
FEI: 3013172450 • Guadalajara • MEXICO
FEI Number
3013172450
Location
Guadalajara
Country
MEXICOAddress
Calle 6 No 2924 Zona in, , Guadalajara, , 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 |
|---|---|---|---|
| 11/14/2025 | 60ICY12SODIUM CITRATE (ALKALIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/14/2025 | 60ICY12SODIUM CITRATE (ALKALIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2025 | 56BDP05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 3/24/2025 | 56ACZ10PENICILLIN G, NATURAL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/15/2024 | 61EDA06FEXOFENADINE HCL (ANTI-ASTHMATIC) | Division of Southeast Imports (DSEI) | |
| 9/20/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 56CDB70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/23/2020 | 64LDL19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/23/2020 | 62GDL94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/28/2019 | 56BCY52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/28/2019 | 56CCY70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/10/2017 | 60LCY90ZOLMITRIPTAN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2017 | 56ACY10PENICILLIN G, NATURAL | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/28/2017 | 64LDY19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 56CDY70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 56CDY70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 56BDY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2017 | 64LDY19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/10/2017 | 56CDY70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/10/2017 | 56CDY70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/10/2017 | 56BDY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/5/2017 | 64LCA56PREDNISONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 8/9/2016 | 61TCK07DIPHENIDOL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PISA SA DE CV's FDA import refusal history?
PISA SA DE CV (FEI: 3013172450) has 24 FDA import refusal record(s) in our database, spanning from 8/9/2016 to 11/14/2025.
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. PISA SA DE CV's FEI number is 3013172450.
What types of violations has PISA SA DE CV received?
PISA SA DE CV 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 PISA SA DE CV come from?
All FDA import refusal data for PISA SA DE CV 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.