FDA Inspection 1090021 — Accord Media, LLC
The FDA completed an inspection of Accord Media, LLC on May 13, 2019 in New York, 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
- May 13, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3314 | 21 CFR 820.120(e) | Control number {see also 820.65, 820.184(f)} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |