FDA Inspection 764439 — Primary Health Care Associates
The FDA completed an inspection of Primary Health Care Associates on January 25, 2012 in Orlando, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 25, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |