FDA Inspection 965674 — Precision Ocular Network
The FDA completed an inspection of Precision Ocular Network on Mar 4, 2016 in Birmingham, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 4, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Birmingham, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12400 | 21 CFR 1271.230(a) | Documented, dated, signed |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |