FDA Inspection
Softgel Healthcare Private LimitedSoftgel Healthcare Private Limited – FDA Inspection, Jun 29, 2012
Record Details
This FDA Inspection record concerns Softgel Healthcare Private Limited, with an inspection on June 29, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 29, 2012
- Product Type
- Drugs
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ID · 2679ae47-b832-419e-942a-1bb7a1fe9cb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 789360
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Softgel Healthcare Private Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| February 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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