FDA Inspection
Softech Pharma Pvt. Ltd.Softech Pharma Pvt. Ltd. – FDA Inspection, Feb 10, 2017
Record Details
This FDA Inspection record concerns Softech Pharma Pvt. Ltd., with an inspection on February 10, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 31b5767d-6b5d-45aa-96a4-c77b7b7c8df6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002973
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Softech Pharma Pvt. Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2025 | Not classified | Office of Inspections and Investigations | |
| December 13, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 11, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Softech Pharma Pvt. Ltd.
- FDA Inspection 1266353 - 2025-03-07
- FDA Inspection 1115367 - 2019-12-13
- FDA Inspection 954258 - 2015-12-11
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