FDA Inspection
Indoco Remedies Limited (Plant I)Indoco Remedies Limited (Plant I) – FDA Inspection, Jan 20, 2023
Record Details
This FDA Inspection record concerns Indoco Remedies Limited (Plant I), with an inspection on January 20, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3929b3c2-419a-400f-93fc-59cb565e1f32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195229
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
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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 25, 2019 | Not classified | Office of Inspections and Investigations | 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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