Pfizer Ireland Pharmaceuticals Unlimited Company
Form 483 issued November 12, 2019 · Dublin, Ireland
- Inspection
- Nov 4 – Nov 12, 2019
- Investigator
- Mihaly S. Ligmond
- Observations
- 2
- Pages
- 3
- FEI number
- 3004145594
In short: On November 12, 2019, FDA issued a Form 483 with 2 observations to Pfizer Ireland Pharmaceuticals Unlimited Company in Dublin, Ireland (FEI 3004145594) after an inspection that ran Nov 4 – Nov 12, 2019. The investigator was Mihaly S. Ligmond. Most observations concern biologics CGMP and quality system; the most-cited regulation is 21 CFR 600.14 (reporting of biological product deviations by licensed manufacturers).
At a glance
Biologics CGMP and quality system account for 2 of 2 observations.
Most cited: 21 CFR 600.14(a)(1) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to submit biological…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
The firmPfizer Ireland Pharmaceuticals Unlimited Company history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 600.14(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer Ireland Pharmaceuticals Unlimited Company?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP and quality system. The most-cited regulation is 21 CFR 600.14 (reporting of biological product deviations by licensed manufacturers). The opening words of each observation are shown on this page.
Who inspected Pfizer Ireland Pharmaceuticals Unlimited Company?
Mihaly S. Ligmond is named on this Form 483, for the inspection of Nov 4 – Nov 12, 2019. Each investigator has a profile showing what they cite most.
When was Pfizer Ireland Pharmaceuticals Unlimited Company inspected by FDA?
The inspection ran Nov 4 – Nov 12, 2019, and the Form 483 is dated November 12, 2019.
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.