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•United States

AbbVie Ltd, Barceloneta, PR – FDA Inspections

Inspection records and compliance data for AbbVie Ltd in Barceloneta, Puerto Rico. 9 FDA inspections on record, last inspected April 18, 2024.

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Company Profile

This profile covers AbbVie Ltd based in Barceloneta, Puerto Rico, United States.

FDA Inspection History

FDA inspections
9
OAI
0
VAI
8
NAI
1
Form 483s
0
Warning letters
0

First inspected February 26, 2009. Last inspected April 18, 2024.

Most cited issue areas

  • Determination not to conduct investigation of complaint1 inspection
  • Investigations of discrepancies, failures1 inspection
  • Procedures for non-sterile drug products1 inspection

FDA inspections (9)

DateResultFDA center(s)Insp. #
April 18, 2024VAIHuman Drugs · Drug Quality Assurance1231256
February 20, 2020VAIHuman Drugs · Drug Quality Assurance1118386
December 21, 2018NAIHuman Drugs · Drug Quality Assurance1081767
July 29, 2016VAIHuman Drugs · Drug Quality Assurance981552
May 20, 2014VAIHuman Drugs · Drug Quality Assurance879731
March 29, 2012VAIHuman Drugs · Drug Quality Assurance774513
March 14, 2011VAIHuman Drugs · Drug Quality Assurance715165
January 21, 2010VAIHuman Drugs · Drug Quality Assurance639503
February 26, 2009VAIHuman Drugs · Drug Quality Assurance568924
FDA documents

Form 483s (2)

  • Form 483s · April 18, 2024
  • Form 483s · February 20, 2020

EIRs (1)

  • EIRs · December 21, 2018
People (6)
David E. Russell
Person
Efrain Rosario
Person
Ivis L. Negron Torres
Person
Noreen Muniz
Person
Libia Lugo
Person
Libia M. Lugo
Person
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Company Information

Name

AbbVie Ltd

FEI Number

3000210838

Address

State Road No 2 Km 58 Cruce Davila, Barceloneta, Puerto Rico 00617, United States

Country

United States

ID: b07cdd9b-e7d5-4b8b-b31d-3cc5dd0c3775

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