Pfizer Ireland Pharmaceuticals Unlimited Company
Form 483 issued January 26, 2018 · RINGASKIDDY, Ireland
- Inspection
- Jan 22 – Jan 26, 2018
- Investigator
- Ariel Cruz Figueroa
- Observations
- 1
- Pages
- 2
- FEI number
- 3002807852
In short: On January 26, 2018, FDA issued a Form 483 with 1 observation to Pfizer Ireland Pharmaceuticals Unlimited Company in RINGASKIDDY, Co. Cork (FEI 3002807852) after an inspection that ran Jan 22 – Jan 26, 2018. The investigator was Ariel Cruz Figueroa. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm fails to establish controls to prevent that non sterile active pharmaceutical ingredients intended J…
This inspection in context
Ariel Cruz Figueroa
16 documents · 2015–2023
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmPfizer Ireland Pharmaceuticals Unlimited Company history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Pfizer Ireland Pharmaceuticals Unlimited Company?
Ariel Cruz Figueroa is named on this Form 483, for the inspection of Jan 22 – Jan 26, 2018. Each investigator has a profile showing what they cite most.
When was Pfizer Ireland Pharmaceuticals Unlimited Company inspected by FDA?
The inspection ran Jan 22 – Jan 26, 2018, and the Form 483 is dated January 26, 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.