FDA Inspection 752063 — Ortho Pros, Inc.
The FDA completed an inspection of Ortho Pros, Inc. on Oct 21, 2011 in Littleton, 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). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 21, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Littleton, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12334 | 21 CFR 1271.170(c) | Trained or re-trained as necessary |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12414 | 21 CFR 1271.260(d) | Corrective actions |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 12424 | 21 CFR 1271.265(c)(1) | Release criteria verified, documented |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |