FDA Inspection 1177895 — Omni-Guide Holdings, Inc.
The FDA completed an inspection of Omni-Guide Holdings, Inc. on August 19, 2022 in Billerica, MA. 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, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Billerica, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |