FDA Inspection 891721 — Zenometrics Llc
The FDA completed an inspection of Zenometrics Llc on August 19, 2014 in Peekskill, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Peekskill, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |