FDA Inspection 1037688 — Asahi Kasei Medical America Inc Memphis Distribution Center
The FDA completed an inspection of Asahi Kasei Medical America Inc Memphis Distribution Center on Jan 11, 2018 in Glenview, 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 11, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Glenview, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |