FDA Inspection
Tenshi Kaizen Private Ltd.Tenshi Kaizen Private Ltd. – FDA Inspection, Sep 13, 2024
Record Details
This FDA Inspection record concerns Tenshi Kaizen Private Ltd., with an inspection on September 13, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · e8f69da1-76db-4cb2-bccd-575f3a4a7dee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249248
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(1)Sample size - test intervals
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Other FDA inspections of Tenshi Kaizen Private Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2019 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
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