FDA Inspection
Cipla LimitedCipla Limited – FDA Inspection, Jan 28, 2019
Record Details
This FDA Inspection record concerns Cipla Limited, with an inspection on January 28, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Angela E. Glenn (Issuing Officer)
- Cheryl A. Clausen
View Company Profile
ID · f442d154-0a0c-46ea-ba3d-7b670aa57332
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078911
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Cipla Limited
13| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| June 21, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 26, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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