FDA Inspection 611822 — Ocular Systems, Inc.
The FDA completed an inspection of Ocular Systems, Inc. on Sep 9, 2009 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). 23 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 9, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12328 | 21 CFR 1271.160(d) | Validation for intended use |
| 12348 | 21 CFR 1271.190(c) | Separate or defined operational areas |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12367 | 21 CFR 1271.200(a) | Design appropriate, suitably located |
| 12370 | 21 CFR 1271.200(c) | Calibration procedures and schedules (general) |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12405 | 21 CFR 1271.250(a) | Controlling the labeling of HCT/Ps |
| 12408 | 21 CFR 1271.250(c) | All labeling requirements met |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12421 | 21 CFR 1271.265(a) | Acceptance criteria designed to prevent CD |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12444 | 21 CFR 1271.270(e) | Contract firms--identities and responsibilities |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |
| 12473 | 21 CFR 1271.350(b)(2) | Deviations not reported to FDA |
| 15019 | 21 CFR 1271.160(d) | Computer software verification |