FDA Inspection
A Solutions, Inc.A Solutions, Inc. – FDA Inspection, Aug 26, 2009
Record Details
This FDA Inspection record concerns A Solutions, Inc., with an inspection on August 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- A Solutions, Inc.
- Inspection Date
- August 26, 2009
- Product Type
- Devices
View Company Profile
ID · 5d89d284-c92c-46fa-8ff8-77e9239a007a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 603594
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
- 21 CFR 820.50(a)(2)Supplier oversight
Full citation text and observation details available on the Dashboard.
Other FDA inspections of A Solutions, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 16, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 13, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 21, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for A Solutions, Inc.
- FDA Inspection 1264096 - 2025-03-13
- FDA Inspection 1107437 - 2019-10-16
- FDA Inspection 980097 - 2016-07-13
- FDA Inspection 880642 - 2014-05-21
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.