FDA Inspection
Titan USA, LLC formerly AmstechTitan USA, LLC formerly Amstech – FDA Inspection, Jun 23, 2009
Record Details
This FDA Inspection record concerns Titan USA, LLC formerly Amstech, with an inspection on June 23, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 23, 2009
- Product Type
- Devices
View Company Profile
ID · a99a0800-023d-4aab-b640-9120c8a5f05e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 591327
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
6- 21 CFR 1040.10(h)(1)(i)User information, adequate instructions
- 21 CFR 1040.10(f)(4)Key control
- 21 CFR 1040.10(f)(3)Remote interlock connector
- 21 CFR 1040.10(f)(6)(i)Beam attenuator
- 21 CFR 1040.10(h)(1)(iv)User info - list controls, etc.
- 21 CFR 1002.30(a)(2)Methods, devices, procedures for testing
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Other FDA inspections of Titan USA, LLC formerly Amstech
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2012 | OAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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