FDA Inspection 720264 — Ultralite Enterprises Inc
The FDA completed an inspection of Ultralite Enterprises Inc on Apr 18, 2011 in Dacula, GA. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 18, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dacula, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |