FDA Inspection
Softgel Healthcare Private LimitedSoftgel Healthcare Private Limited – FDA Inspection, Feb 22, 2019
Record Details
This FDA Inspection record concerns Softgel Healthcare Private Limited, with an inspection on February 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d3345b24-4973-4735-ad25-046e5c23e99c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1080044
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.52Washing and toilet facilities not provided and accessible
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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 |
| April 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 29, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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