FDA Inspection
Accogent, LLCAccogent, LLC – FDA Inspection, Jul 27, 2013
Record Details
This FDA Inspection record concerns Accogent, LLC, with an inspection on July 27, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Accogent, LLC
- Inspection Date
- July 27, 2013
- Product Type
- Devices
View Company Profile
ID · fc6e0b93-0bf1-43bb-867c-7b8cf366d907
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 843887
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
5- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 1002.41(a)(1)Forwarding, holding, preserving distribution data
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