FDA Inspection 1070564 — The Morel Company, LLC
The FDA completed an inspection of The Morel Company, LLC on Nov 1, 2018 in Batesville, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 1, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Batesville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |