FDA Inspection
Repro Lab, Inc.Repro Lab, Inc. – FDA Inspection, Nov 19, 2024
Record Details
This FDA Inspection record concerns Repro Lab, Inc., with an inspection on November 19, 2024, issued by the New York District Office, covering biologics.
- Office
- New York District Office
- Person
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ID · 14a1802d-30a7-4b9c-9b55-a256b7aad146
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1255573
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.75(e)Abbreviated procedure
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Repro Lab, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2022 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 16, 2020 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 19, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 8, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 17, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Repro Lab, Inc.
- FDA Inspection 1172852 - 2022-06-24
- FDA Inspection 1131538 - 2020-10-16
- FDA Inspection 1045046 - 2018-03-19
- FDA Inspection 961911 - 2016-03-08
- FDA Inspection 895463 - 2014-09-17
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