FDA Inspection 1179584 — OMM Imports, Inc.
The FDA completed an inspection of OMM Imports, Inc. on Sep 9, 2022 in Miami Beach, FL. 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). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 9, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Miami Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5042 | 21 CFR 1010.3(a) | ID label or tag |
| 5199 | 21 CFR 1040.10(h)(1)(iii) | Legible reproductions |
| 5200 | 21 CFR 1040.10(h)(1)(iv) | User info - list controls, etc. |
| 5209 | 21 CFR 1040.11(a)(3) | Aperture label |