FDA Inspection
Repro Lab, Inc.Repro Lab, Inc. – FDA Inspection, Mar 8, 2016
Record Details
This FDA Inspection record concerns Repro Lab, Inc., with an inspection on March 8, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Repro Lab, Inc.
- Inspection Date
- March 8, 2016
- Product Type
- Biologics
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ID · 40330317-aa57-45bd-b4d0-311c314ed545
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 961911
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.47(a)Procedures for all other requirements
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Other FDA inspections of Repro Lab, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2024 | VAI | New York District Office | Human Cellular, Tissue, and Gene Therapies |
| 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 |
| September 17, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Repro Lab, Inc.
- FDA Inspection 1255573 - 2024-11-19
- FDA Inspection 1172852 - 2022-06-24
- FDA Inspection 1131538 - 2020-10-16
- FDA Inspection 1045046 - 2018-03-19
- FDA Inspection 895463 - 2014-09-17
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