Polpharma Biologics S.A.
Form 483 issued March 22, 2022 · Gdansk, Poland
- Investigators
- Jacek Cieslak· Panied Jacek Cieslak
- Observations
- 11
- Pages
- 6
- FEI number
- 3013195136
In short: On March 22, 2022, FDA issued a Form 483 with 11 observations to Polpharma Biologics S.A. in Gdansk, Poland (FEI 3013195136). The investigators were Jacek Cieslak and Panied Jacek Cieslak. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures which monitor the output and validate the performance of those manufacturing processes that may…
- 02
Procedures to ensure sampling methods are adequate for their intended use have not been fully established…
- 03
Processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Changes made to processes are not always fully evaluated concerning impact on quality to determine what…
This inspection in context
Jacek Cieslak
6 documents · 2019–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Japan.
The firmPolpharma Biologics S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Polpharma Biologics S.A.?
FDA listed 11 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Polpharma Biologics S.A.?
Jacek Cieslak and Panied Jacek Cieslak are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Polpharma Biologics S.A. inspected by FDA?
This Form 483 is dated March 22, 2022.
How do I get the full Form 483 for Polpharma Biologics S.A.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.