FDA Inspection 722618 — Center For Organ Recovery & Education
The FDA completed an inspection of Center For Organ Recovery & Education on May 12, 2011 in Pittsburgh, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 12, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12424 | 21 CFR 1271.265(c)(1) | Release criteria verified, documented |