FDA Inspection
7 Mile Solutions Inc., dba Maxant Technologies7 Mile Solutions Inc., dba Maxant Technologies – FDA Inspection, Jun 25, 2013
Record Details
This FDA Inspection record concerns 7 Mile Solutions Inc., dba Maxant Technologies, with an inspection on June 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 25, 2013
- Product Type
- Devices
View Company Profile
ID · 6bbed637-0464-4fae-ba81-2453eeccd2d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 837600
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of 7 Mile Solutions Inc., dba Maxant Technologies
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for 7 Mile Solutions Inc., dba Maxant Technologies
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.