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FDA Inspection
•Natco Pharma Limited•August 21, 2026

Natco Pharma Limited – FDA Inspection, Aug 21, 2026

Record Details

This FDA Inspection record concerns Natco Pharma Limited, with an inspection on August 21, 2026, issued by the Office of Inspections and Investigations, covering human drugs.

Company
Natco Pharma Limited
Inspection Date
August 21, 2026
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • Bryan L. Mcguckin
View Company Profile

ID · b15c6908-585a-4b13-977b-36df87c1ddcd

Inspection Facts

Inspection number
1331920
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 211.46(b)Equipment for Environmental Control
  2. 21 CFR 211.67(b)(4)Cleaning SOPs/equipment identification
  3. 21 CFR 211.68(a)Calibration/Inspection/Checking not done
  4. 21 CFR 211.84(d)(1)Component identity verification

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Natco Pharma Limited

1
DateClassificationOfficeProject area
February 3, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Natco Pharma Limited
  • FDA Inspection 1198251 - 2023-02-03

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