FDA Inspection 1115002 — DDC Technologies, Inc.
The FDA completed an inspection of DDC Technologies, Inc. on January 8, 2020 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
- January 8, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Oceanside, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |