Pfizer Ireland Pharmaceuticals Unlimited Company
Form 483 issued September 18, 2018 · Dublin, Ireland
- Inspection
- Sep 10 – Sep 18, 2018
- Investigators
- Mihaly S. Ligmond· Scott E. Norris
- Observations
- 4
- Pages
- 3
- FEI number
- 3004145594
In short: On September 18, 2018, FDA issued a Form 483 with 4 observations to Pfizer Ireland Pharmaceuticals Unlimited Company in Dublin, Ireland (FEI 3004145594) after an inspection that ran Sep 10 – Sep 18, 2018. The investigators were Mihaly S. Ligmond and Scott E. Norris. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
(b)(4) processing areas are deficient regarding the system…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
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 211.192
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 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Pfizer Ireland Pharmaceuticals Unlimited Company?
Mihaly S. Ligmond and Scott E. Norris are named on this Form 483, for the inspection of Sep 10 – Sep 18, 2018. Each investigator has a profile showing what they cite most.
When was Pfizer Ireland Pharmaceuticals Unlimited Company inspected by FDA?
The inspection ran Sep 10 – Sep 18, 2018, and the Form 483 is dated September 18, 2018.
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.