FDA Inspection 683197 — Ocular Systems, Inc.
The FDA completed an inspection of Ocular Systems, Inc. on Sep 29, 2010 in Aurora, CO. 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). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 29, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |
| 12323 | 21 CFR 1271.160(b)(5) | Monitoring systems |
| 12328 | 21 CFR 1271.160(d) | Validation for intended use |
| 12332 | 21 CFR 1271.170(b) | Qualifications lacking |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |