FDA Inspection
InControl Medical, LLCInControl Medical, LLC – FDA Inspection, Jul 17, 2013
Record Details
This FDA Inspection record concerns InControl Medical, LLC, with an inspection on July 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- InControl Medical, LLC
- Inspection Date
- July 17, 2013
- Product Type
- Devices
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ID · 4f07ced2-4ea5-4fe1-a99a-6c30b188d750
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 840481
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of InControl Medical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 21, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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