FDA Inspection
Overlake Reproductive Health Laboratory LLCOverlake Reproductive Health Laboratory LLC – FDA Inspection, Apr 19, 2016
Record Details
This FDA Inspection record concerns Overlake Reproductive Health Laboratory LLC, with an inspection on April 19, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 19, 2016
- Product Type
- Biologics
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ID · 4c39c574-df74-47e3-b1a1-80e501206be5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967310
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Overlake Reproductive Health Laboratory LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 27, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 9, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 17, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 5, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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