FDA Inspection
7 Mile Solutions Inc., dba Maxant Technologies7 Mile Solutions Inc., dba Maxant Technologies – FDA Inspection, Dec 17, 2015
Record Details
This FDA Inspection record concerns 7 Mile Solutions Inc., dba Maxant Technologies, with an inspection on December 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 17, 2015
- Product Type
- Devices
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ID · f58d84d7-3fe2-4f49-b8be-d842522ac0c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 963497
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of 7 Mile Solutions Inc., dba Maxant Technologies
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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