FDA Inspection
Repro Lab, Inc.Repro Lab, Inc. – FDA Inspection, Aug 21, 2012
Record Details
This FDA Inspection record concerns Repro Lab, Inc., with an inspection on August 21, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Repro Lab, Inc.
- Inspection Date
- August 21, 2012
- Product Type
- Biologics
View Company Profile
ID · 3b755c83-67e6-4719-9a45-b5c510d8d7cb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 795113
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
Full citation text and observation details available on the Dashboard.
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 |
| March 8, 2016 | 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 961911 - 2016-03-08
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