FDA Inspection 718273 — Alabama Organ Center - Mobile Region
The FDA completed an inspection of Alabama Organ Center - Mobile Region on March 24, 2011 in Mobile, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Mobile, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12342 | 21 CFR 1271.190(a) | Size, construction, location--prevent mix-ups etc. |
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |