FDA Inspection 721393 — Old School Medical LLC
The FDA completed an inspection of Old School Medical LLC on Apr 6, 2011 in Summit, IL. 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
- Apr 6, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Summit, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12438 | 21 CFR 1271.270(b) | Management system re: core CGTPs |