FDA Inspection 794470 — Reproductive Institute of South Texas
The FDA completed an inspection of Reproductive Institute of South Texas on August 10, 2012 in Mcallen, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 10, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mcallen, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12224 | 21 CFR 1271.47(c) | Availability of procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 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 |