FDA Inspection
Westlake IVF, LLCWestlake IVF, LLC – FDA Inspection, Dec 11, 2023
Record Details
This FDA Inspection record concerns Westlake IVF, LLC, with an inspection on December 11, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 3664ffa4-bbff-4e1f-a335-237df74fb9c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224705
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.90(c)Eligibility not required--warning labels
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Other FDA inspections of Westlake IVF, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2021 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 31, 2019 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 31, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 5, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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