FDA Inspection 1034820 — DDC Technologies, Inc.
The FDA completed an inspection of DDC Technologies, Inc. on December 7, 2017 in Oceanside, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 7, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Oceanside, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |