Zaklady Farmaceutyczne Polpharma S.A. FDA Record
- Latest inspection VAI · Oct 17, 2025
- No warning letters matched by name
Zaklady Farmaceutyczne Polpharma S.A. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Zaklady Farmaceutyczne Polpharma S.A." is on file.
- Latest inspection
- Oct 17, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 5 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Zaklady Farmaceutyczne Polpharma S.A.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 17, 2025 | Starogard Gdanski, Poland | Drugs | Voluntary Action Indicated (VAI) | 3002807920 |
| May 25, 2018 | Starogard Gdanski, Poland | Drugs | Voluntary Action Indicated (VAI) | 3002807920 |
| Jan 29, 2015 | Starogard Gdanski, Poland | Drugs | No Action Indicated (NAI) | 3002807920 |
| Sep 20, 2012 | Starogard Gdanski, Poland | Drugs | No Action Indicated (NAI) | 3002807920 |
| Jan 29, 2009 | Starogard Gdanski, Poland | Drugs | No Action Indicated (NAI) | 3002807920 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002807920 | Starogard Gdanski, Poland | 5 | Oct 17, 2025 |
Zaklady Farmaceutyczne Polpharma S.A. and the FDA: common questions
Has Zaklady Farmaceutyczne Polpharma S.A. received an FDA warning letter?
No FDA warning letter addressed to the name "Zaklady Farmaceutyczne Polpharma S.A." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Zaklady Farmaceutyczne Polpharma S.A. received an FDA Form 483?
FDA has not published a Form 483 for "Zaklady Farmaceutyczne Polpharma S.A." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Zaklady Farmaceutyczne Polpharma S.A.?
The most recent FDA inspection on file ended Oct 17, 2025 at Starogard Gdanski, Poland and was classified VAI. FDA has 5 inspections of Zaklady Farmaceutyczne Polpharma S.A. on file.
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