FDA Inspection 1074919 — Valtronic Technologies Inc.
The FDA completed an inspection of Valtronic Technologies Inc. on December 19, 2018 in Solon, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 19, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Solon, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |