Steriscience
Poland Updated 9 July 2026
Steriscience is a finished-dose manufacturer based in Poland. It appears in 72 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, US FDA and AIFA (IT). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 28 April 2023 as VAI.
2
registered plants
1 with an FDA FEI number
72
filings
across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Inspection history
- 28 April 2023 VAI US FDA
- 14 February 2014 OAI US FDA
- 13 September 2012 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Poland, Poland | 3009685660 |
| Warsaw, Poland | Not on file |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| EMA | 44 | 1 |
| US FDA | 11 | None |
| AIFA (IT) | 5 | None |
| AEMPS (ES) | 4 | None |
| INFARMED (PT) | 3 | None |
| MPA (SE) | 2 | None |
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Open risk flags
- The most recent inspection outcome was VAI, on 28 April 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates