FDA Inspection
Comit Developers LlcComit Developers Llc – FDA Inspection, Dec 15, 2017
Record Details
This FDA Inspection record concerns Comit Developers Llc, with an inspection on December 15, 2017, issued by the New Orleans District Office, covering medical devices & rad health.
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ID · 85f8e6f9-ec35-4c30-ad51-00e07cc0c8a3
Inspection Facts
- Inspection number
- 1035246
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Documentation of software validation
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