FDA Inspection
Creative Marketing ConceptsCreative Marketing Concepts – FDA Inspection, Sep 17, 2014
Record Details
This FDA Inspection record concerns Creative Marketing Concepts, with an inspection on September 17, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Creative Marketing Concepts
- Inspection Date
- September 17, 2014
- Product Type
- Devices
View Company Profile
ID · f76c5a6f-c699-4705-8c89-fa583433f96e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 899274
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 803.17Lack of Written MDR Procedures
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