FDA Inspection 789421 — Westlake IVF, LLC
The FDA completed an inspection of Westlake IVF, LLC on July 5, 2012 in Austin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 5, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12224 | 21 CFR 1271.47(c) | Availability of procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12238 | 21 CFR 1271.55(b)(1) | Statement re: certified testing lab |