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FDA Inspection
•Mankind Pharma Limited•March 25, 2025

Mankind Pharma Limited – FDA Inspection, Mar 25, 2025

Record Details

This FDA Inspection record concerns Mankind Pharma Limited, with an inspection on March 25, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Mankind Pharma Limited
Inspection Date
March 25, 2025
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • Unnee Ranjan (FDA Associated Person)
View Company Profile

ID · ae972d29-c162-44e8-8967-75511b74eb23

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1264766
FDA center
Human Drugs
Project area
Generic Drug Evaluation
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 211.160(b)Scientifically sound laboratory controls
  2. 21 CFR 211.63Equipment Design, Size and Location
  3. 21 CFR 211.67(b)(3)Cleaning SOPs/instructions

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mankind Pharma Limited

3
DateClassificationOfficeProject area
February 25, 2022VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 11, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 17, 2018Not classifiedOffice of Inspections and Investigations
Other documents for Mankind Pharma Limited
  • FDA Inspection 1163175 - 2022-02-25
  • FDA Inspection 1076707 - 2019-01-11
  • FDA Inspection 1068711 - 2018-09-17

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