Pfizer Ireland Pharmaceuticals Unlimited Company — FDA Facility Profile

FEI 3006785053

Pfizer Ireland Pharmaceuticals Unlimited Company is an FDA-registered facility (FEI 3006785053) located in Newbridge, IE. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 8 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 23, 2022: Voluntary Action Indicated (VAI)
Inspections on record
8 (5 VAI, 3 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Sep 23, 2022Voluntary Action Indicated (VAI)No citations listed
Sep 27, 2019Voluntary Action Indicated (VAI)No citations listed
Apr 13, 2018No Action Indicated (NAI)No citations listed
Jul 29, 2016Voluntary Action Indicated (VAI)No citations listed
Jun 12, 2015Voluntary Action Indicated (VAI)No citations listed
Feb 8, 2013No Action Indicated (NAI)No citations listed
Oct 24, 2011No Action Indicated (NAI)No citations listed
Aug 20, 2009Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Pfizer Ireland Pharmaceuticals Unlimited Company
Location
Newbridge (IE)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
Source
decrs

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.