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FDA Inspection
•Choksi Laboratories Limited•August 20, 2026

Choksi Laboratories Limited – FDA Inspection, Aug 20, 2026

Record Details

This FDA Inspection record concerns Choksi Laboratories Limited, with an inspection on August 20, 2026, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Choksi Laboratories Limited
Inspection Date
August 20, 2026
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • David A. Oluwo (FDA Associated Person)
View Company Profile

ID · 5420704c-6ea6-41a9-88c8-a3e2f83bdd52

Inspection Facts

Inspection number
1334178
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
  2. 21 CFR 211.165(e)Test methods
  3. 21 CFR 211.192Investigations of discrepancies, failures
  4. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Choksi Laboratories Limited

5
DateClassificationOfficeProject area
September 6, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 25, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 1, 2016VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 12, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 14, 2010VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Choksi Laboratories Limited
  • FDA Inspection 1101549 - 2019-09-06
  • FDA Inspection 1053312 - 2018-04-25
  • FDA Inspection 974173 - 2016-06-01
  • FDA Inspection 867346 - 2014-01-12
  • FDA Inspection 673062 - 2010-07-14

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