FDA Inspection 856462 — Midway Medical Products, Inc.
The FDA completed an inspection of Midway Medical Products, Inc. on Nov 22, 2013 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). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 22, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Saint Charles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12334 | 21 CFR 1271.170(c) | Trained or re-trained as necessary |
| 12337 | 21 CFR 1271.180(a) | Design adequate to bar spread of CD's |
| 12361 | 21 CFR 1271.195(b) | Periodic inspection |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12429 | 21 CFR 1271.265(d) | Shipping conditions appropriate |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |