FDA Inspection
Indoco Remedies LimitedIndoco Remedies Limited – FDA Inspection, Jun 4, 2019
Record Details
This FDA Inspection record concerns Indoco Remedies Limited, with an inspection on June 4, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 3cc8b171-e1c6-4ae1-b1a0-b8237ca02efa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1091776
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192Extent of discrepancy, failure investigations
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Other FDA inspections of Indoco Remedies Limited
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2026 | Not classified | Office of Inspections and Investigations | |
| July 26, 2024 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| February 28, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 4, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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