FDA Inspection 1175810 — Allison Medical, Inc.
The FDA completed an inspection of Allison Medical, Inc. on July 29, 2022 in Littleton, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 29, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Littleton, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 4436 | 21 CFR 803.40(a) | Report of death, injury |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |