Zaklady Farmaceutyczne Polpharma S a
Form 483 issued May 25, 2018 · Starogard Gdanski, Poland
- Inspection
- May 21 – May 25, 2018
- Investigator
- Devver Brown
- Observations
- 2
- Pages
- 2
- FEI number
- 3002807920
In short: On May 25, 2018, FDA issued a Form 483 with 2 observations to Zaklady Farmaceutyczne Polpharma S a in Starogard Gdanski, Pomorskie (FEI 3002807920) after an inspection that ran May 21 – May 25, 2018. The investigator was Devver Brown. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.166 (1×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures have not…
- 02
Employees have not received the training required to…
This inspection in context
Devver Brown
1 document · 2018
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Poland.
The firmZaklady Farmaceutyczne Polpharma S a history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zaklady Farmaceutyczne Polpharma S a?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Zaklady Farmaceutyczne Polpharma S a?
Devver Brown is named on this Form 483, for the inspection of May 21 – May 25, 2018. Each investigator has a profile showing what they cite most.
When was Zaklady Farmaceutyczne Polpharma S a inspected by FDA?
The inspection ran May 21 – May 25, 2018, and the Form 483 is dated May 25, 2018.
How do I get the full Form 483 for Zaklady Farmaceutyczne Polpharma 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.