FDA Inspection
Indoco Remedies Limited (Plant I)Indoco Remedies Limited (Plant I) – FDA Inspection, Jan 25, 2019
Record Details
This FDA Inspection record concerns Indoco Remedies Limited (Plant I), with an inspection on January 25, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · b4144757-df21-46fe-9d8b-54c0752c8d7f
Inspection Facts
- Inspection number
- 1077464
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Indoco Remedies Limited (Plant I)
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2023 | VAI | Office of Inspections and Investigations | |
| January 20, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 19, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 29, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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