FDA Inspection 738722 — Louisiana Organ Procurement Agency
The FDA completed an inspection of Louisiana Organ Procurement Agency on February 18, 2011 in Covington, LA. 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
- February 18, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Covington, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |