FDA Inspection
ClinSync Clinical Research Pvt LtdClinSync Clinical Research Pvt Ltd – FDA Inspection, Apr 21, 2017
Record Details
This FDA Inspection record concerns ClinSync Clinical Research Pvt Ltd, with an inspection on April 21, 2017, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · d2570523-f704-474a-8a43-c1aa7463b649
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1010649
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(c)Record retention
- 21 CFR 312.64(c)Final study report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ClinSync Clinical Research Pvt Ltd
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2025 | Not classified | Office of Inspections and Investigations | |
| January 19, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 10, 2020 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 2, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for ClinSync Clinical Research Pvt Ltd
- FDA Inspection 1291102 - 2025-10-24
- FDA Inspection 1198366 - 2023-01-19
- FDA Inspection 1120765 - 2020-01-10
- FDA Inspection 1020936 - 2017-06-02
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