FDA Inspection
Sidmak Laboratories India Pvt LtdSidmak Laboratories India Pvt Ltd – FDA Inspection, Aug 26, 2026
Record Details
This FDA Inspection record concerns Sidmak Laboratories India Pvt Ltd, with an inspection on August 26, 2026, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 8d33394a-bf68-49aa-bf5f-c9275266ab79
Inspection Facts
- Inspection number
- 1334910
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Sidmak Laboratories India Pvt Ltd
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 14, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 6, 2019 | OAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| March 31, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 6, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sidmak Laboratories India Pvt Ltd
- FDA Inspection 1207996 - 2023-05-13
- FDA Inspection 1123559 - 2020-02-14
- FDA Inspection 1102227 - 2019-09-06
- FDA Inspection 1009631 - 2017-03-31
- FDA Inspection 881291 - 2014-06-06
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