FDA Inspection
ENERGON LABS PRIVATE LIMITEDENERGON LABS PRIVATE LIMITED – FDA Inspection, Jan 13, 2023
Record Details
This FDA Inspection record concerns ENERGON LABS PRIVATE LIMITED, with an inspection on January 13, 2023, issued by the Office of Inspections and Investigations.
- Company
- ENERGON LABS PRIVATE LIMITED
- Inspection Date
- January 13, 2023
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ID · 0beb215b-5cf3-4fc0-a014-52236c26e01d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195432
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
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Other FDA inspections of ENERGON LABS PRIVATE LIMITED
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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