FDA Inspection 1083346 — Innomed, Inc.
The FDA completed an inspection of Innomed, Inc. on March 21, 2019 in Savannah, GA. 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
- March 21, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Savannah, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |