FDA Inspection
Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. – FDA Inspection, Oct 27, 2023
Record Details
This FDA Inspection record concerns Dr. Reddy's Laboratories Ltd., with an inspection on October 27, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 18ff5b36-8545-4cb9-a106-1c4afee1be15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1222556
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
20- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Dr. Reddy's Laboratories Ltd.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2026 | Not classified | Office of Inspections and Investigations | |
| February 28, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 28, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 17, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dr. Reddy's Laboratories Ltd.
- FDA Inspection 1330894 - 2026-08-14
- FDA Inspection 1121029 - 2020-02-28
- FDA Inspection 1079024 - 2019-02-08
- FDA Inspection 1010046 - 2017-04-28
- FDA Inspection 940784 - 2015-06-17
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