Pfizer Ireland Pharmaceuticals Unlimited Company
Form 483 issued May 11, 2023 · Dublin, Ireland
- Inspection
- May 3 – May 11, 2023
- Observations
- 1
- Pages
- 1
- FEI number
- 3004145594
In short: On May 11, 2023, FDA issued a Form 483 with 1 observation to Pfizer Ireland Pharmaceuticals Unlimited Company in Dublin, Ireland (FEI 3004145594) after an inspection that ran May 3 – May 11, 2023. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.56 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The cleaning of classified…
This inspection in context
Questions about this 483
What did FDA find at Pfizer Ireland Pharmaceuticals Unlimited Company?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
When was Pfizer Ireland Pharmaceuticals Unlimited Company inspected by FDA?
The inspection ran May 3 – May 11, 2023, and the Form 483 is dated May 11, 2023.
How do I get the full Form 483 for Pfizer Ireland Pharmaceuticals Unlimited Company?
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.