Polpharma Biologics S.A.
FDA inspection history in Gdansk, Poland, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Gdansk, Poland.
Cited most
Across all Polpharma Biologics observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.125Labeling issuance1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
The complete Polpharma Biologics file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Gdansk, Poland
One Form 483 · 2022 · 11 observations
Latest: Form 483, Mar 22, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-22 | 483 Form 483 | Gdansk, Poland | 11 | $99 |
Investigators on these documents
FEI number 3013195136 · most recent document Mar 22, 2022
About Polpharma Biologics S.A.
How many FDA Form 483s has Polpharma Biologics S.A. received?
FDA Intel has 1 Form 483 on file for Polpharma Biologics S.A.; the most recent is dated Mar 22, 2022.
When was Polpharma Biologics S.A. last inspected by FDA?
The most recent FDA inspection document on file for Polpharma Biologics S.A. is a Form 483 dated Mar 22, 2022, for the site in Gdansk, Poland.
What did FDA cite at Polpharma Biologics S.A.?
The regulations cited most in the observations on file for Polpharma Biologics S.A. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.125 (Labeling issuance), 1 time.