FDA Inspection 591327 — Titan USA, LLC formerly Amstech
The FDA completed an inspection of Titan USA, LLC formerly Amstech on June 23, 2009 in Milton, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 23, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Milton, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5150 | 21 CFR 1040.10(f)(3) | Remote interlock connector |
| 5151 | 21 CFR 1040.10(f)(4) | Key control |
| 5197 | 21 CFR 1040.10(h)(1)(i) | User information, adequate instructions |
| 5200 | 21 CFR 1040.10(h)(1)(iv) | User info - list controls, etc. |
| 5358 | 21 CFR 1040.10(f)(6)(i) | Beam attenuator |
| 5813 | 21 CFR 1002.30(a)(2) | Methods, devices, procedures for testing |