FDA Inspection
Prestige AmeritechPrestige Ameritech – FDA Inspection, Mar 27, 2019
Record Details
This FDA Inspection record concerns Prestige Ameritech, with an inspection on March 27, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f415cb7d-3868-41c0-963e-75a00094671d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084042
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Prestige Ameritech
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2024 | Not classified | Dallas District Office | |
| August 20, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 13, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Prestige Ameritech
- FDA Inspection 1227701 - 2024-01-11
- FDA Inspection 1063422 - 2018-08-20
- FDA Inspection 903287 - 2014-11-13
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