FDA Inspection 1168326 — Elite-Medical, LLC
The FDA completed an inspection of Elite-Medical, LLC on Apr 29, 2022 in Florence, AL. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 29, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Florence, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |