FDA Inspection
Allison Medical, Inc.Allison Medical, Inc. – FDA Inspection, Jul 29, 2022
Record Details
This FDA Inspection record concerns Allison Medical, Inc., with an inspection on July 29, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Allison Medical, Inc.
- Inspection Date
- July 29, 2022
- Product Type
- Devices
View Company Profile
ID · ad25b3a8-14da-4fa5-a0d4-6bbf77570789
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1175810
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.40(a)Report of death, injury
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Allison Medical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 12, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 10, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Allison Medical, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.