FDA Inspection
Syngene International LimitedSyngene International Limited – FDA Inspection, Jan 26, 2018
Record Details
This FDA Inspection record concerns Syngene International Limited, with an inspection on January 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Melkamu Getie Kebtie (Issuing Officer)
View Company Profile
ID · e7401b11-a42b-4f4e-862e-7c76c9db7218
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045859
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
Other FDA inspections of Syngene International Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 28, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 14, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 17, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Syngene International Limited
- FDA Inspection 1190200 - 2022-10-28
- FDA Inspection 1123153 - 2020-02-28
- FDA Inspection 1097479 - 2019-06-14
- FDA Inspection 1007912 - 2017-02-17
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