FDA Inspection
Westlake IVF, LLCWestlake IVF, LLC – FDA Inspection, Jul 5, 2012
Record Details
This FDA Inspection record concerns Westlake IVF, LLC, with an inspection on July 5, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Westlake IVF, LLC
- Inspection Date
- July 5, 2012
- Product Type
- Biologics
View Company Profile
ID · 3247169c-daee-422e-afdd-e6520d916033
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 789421
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
- 21 CFR 1271.47(c)Availability of procedures
- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
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Other FDA inspections of Westlake IVF, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2023 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 |
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