FDA Inspection 837597 — Fertility Specialists Of Texas - Lubbock
The FDA completed an inspection of Fertility Specialists Of Texas - Lubbock on Jun 21, 2013 in Lubbock, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 21, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Lubbock, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12494 | 21 CFR 1271.85(c) | Reproductive cells or tissues |