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FDA Inspection
•Pfizer Healthcare India Private Limited•September 6, 2019

Pfizer Healthcare India Private Limited – FDA Inspection, Sep 6, 2019

Record Details

This FDA Inspection record concerns Pfizer Healthcare India Private Limited, with an inspection on September 6, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Pfizer Healthcare India Private Limited
Inspection Date
September 6, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Jose E. Melendez (FDA Associated Person)
View Company Profile

ID · d661c7f5-6120-4820-af7a-3caf6f60c2b8

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1106244
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued
Enforcement
Warning Letter

Other FDA inspections of Pfizer Healthcare India Private Limited

7
DateClassificationOfficeProject area
September 10, 2026Not classifiedOffice of Inspections and InvestigationsDrug Quality Assurance
October 18, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 21, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 17, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 8, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for Pfizer Healthcare India Private Limited
  • FDA Inspection 1335052 - 2026-09-10
  • FDA Inspection 1181610 - 2022-10-18
  • FDA Inspection 1066469 - 2018-09-21
  • FDA Inspection 1006274 - 2017-03-17
  • FDA Inspection 941107 - 2015-09-08

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