FDA Inspection
Tenshi Kaizen Private Ltd.Tenshi Kaizen Private Ltd. – FDA Inspection, Jul 19, 2019
Record Details
This FDA Inspection record concerns Tenshi Kaizen Private Ltd., with an inspection on July 19, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 04119c01-a1b3-447c-afff-331e8575db9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096764
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.44Adequate lighting not provided
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
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Other FDA inspections of Tenshi Kaizen Private Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2024 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
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