FDA Inspection
Prestige AmeritechPrestige Ameritech – FDA Inspection, Aug 20, 2018
Record Details
This FDA Inspection record concerns Prestige Ameritech, with an inspection on August 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b80b56b7-91b7-45e3-b248-254ab2cf5ce0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063422
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Prestige Ameritech
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2024 | Not classified | Dallas District Office | |
| March 27, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1084042 - 2019-03-27
- FDA Inspection 903287 - 2014-11-13
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