FDA Inspection 608848 — Center For Organ Recovery & Education
The FDA completed an inspection of Center For Organ Recovery & Education on September 11, 2009 in Pittsburgh, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 11, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12309 | 21 CFR 1271.160(a) | Program is appropriate for the HCT/Ps |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12405 | 21 CFR 1271.250(a) | Controlling the labeling of HCT/Ps |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12448 | 21 CFR 1271.290(c) | Identification code |