FDA Inspection 1205081 — D. O. Weaver and Company
The FDA completed an inspection of D. O. Weaver and Company on May 12, 2023 in Aurora, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 12, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |