794470
Reproductive Institute of South Texas — FEI 3004611200
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 |