FDA Inspection 1156159 — DDC Technologies, Inc.
The FDA completed an inspection of DDC Technologies, Inc. on October 22, 2021 in Oceanside, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 22, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oceanside, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |