FDA Inspection 731378 — Midway Medical Products, Inc.
The FDA completed an inspection of Midway Medical Products, Inc. on Jun 16, 2011 in Saint Charles, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Saint Charles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12425 | 21 CFR 1271.265(c)(1) | Release of HCT/Ps by responsible person |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |