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Pfizer Ireland Pharmaceuticals Unlimited Company — FDA Facility Profile

FEI 3004145594

Pfizer Ireland Pharmaceuticals Unlimited Company is an FDA-registered facility (FEI 3004145594) located in Dublin, IE. Registered operations: ANALYSIS; API MANUFACTURE; MANUFACTURE; PACK. RegDataLab tracks 11 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Dec 15, 2023: Voluntary Action Indicated (VAI)
Inspections on record
11 (10 VAI, 1 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
2

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

Showing the 10 most recent of 11 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Dec 15, 2023Voluntary Action Indicated (VAI)No citations listed
Nov 12, 2019Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
Who must report - manufacturer (21 CFR 600.14(a)(1))
Nov 9, 2018Voluntary Action Indicated (VAI)No citations listed
Sep 18, 2018Voluntary Action Indicated (VAI)No citations listed
Mar 10, 2017Voluntary Action Indicated (VAI)Deviations from laboratory control requirements (21 CFR 211.160(a))
Sep 20, 2016Voluntary Action Indicated (VAI)No citations listed
Jun 17, 2014Voluntary Action Indicated (VAI)No citations listed
Oct 15, 2013No Action Indicated (NAI)No citations listed
Jun 28, 2012Voluntary Action Indicated (VAI)No citations listed
Aug 31, 2010Voluntary Action Indicated (VAI)No citations listed

Facility details

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

Import refusals

FDA data resources

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