FDA Inspection
Solara Active Pharma Sciences LimitedSolara Active Pharma Sciences Limited – FDA Inspection, Aug 31, 2016
Record Details
This FDA Inspection record concerns Solara Active Pharma Sciences Limited, with an inspection on August 31, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 31, 2016
- Product Type
- Drugs
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ID · 28d75abb-34db-4bba-bb66-0482c631e2ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983873
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of Solara Active Pharma Sciences Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 14, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Solara Active Pharma Sciences Limited
- FDA Inspection 1245977 - 2024-08-09
- FDA Inspection 1077338 - 2018-12-14
- FDA Inspection 813770 - 2012-12-14
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