FDA Inspection
Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. – FDA Inspection, Aug 20, 2019
Record Details
This FDA Inspection record concerns Dr. Reddy's Laboratories Ltd., with an inspection on August 20, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7bcb39d4-1dda-4e64-aa98-e9842b88902b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100841
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
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Other FDA inspections of Dr. Reddy's Laboratories Ltd.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 29, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dr. Reddy's Laboratories Ltd.
- FDA Inspection 1238809 - 2024-05-17
- FDA Inspection 1155431 - 2021-10-29
- FDA Inspection 1095657 - 2019-06-21
- FDA Inspection 1072761 - 2018-10-30
- FDA Inspection 1005630 - 2017-03-08
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