FDA Inspection 1022305 — Ducommun Labarge Technologies
The FDA completed an inspection of Ducommun Labarge Technologies on Aug 11, 2017 in Appleton, WI. 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
- Aug 11, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Appleton, WI (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |