FDA Inspection 590681 — NeoCells, LLC
The FDA completed an inspection of NeoCells, LLC on Jun 17, 2009 in Palm Harbor, FL. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Palm Harbor, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12378 | 21 CFR 1271.210(d)(1) | Receipt documentation maintained |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |