FDA Inspection
Overlake Reproductive Health Laboratory LLCOverlake Reproductive Health Laboratory LLC – FDA Inspection, Sep 27, 2017
Record Details
This FDA Inspection record concerns Overlake Reproductive Health Laboratory LLC, with an inspection on September 27, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 27, 2017
- Product Type
- Biologics
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ID · 4e587122-489d-455f-9ea0-336be9a24fed
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1026748
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.55(b)(3)Name and address on summary
- 21 CFR 1271.55(c)Name and personal info on accompanying records
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.90(c)Eligibility not required--warning labels
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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 |
| April 19, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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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