FDA Inspection
Young Microbrush, LLC dba Microbrush InternationalYoung Microbrush, LLC dba Microbrush International – FDA Inspection, Oct 22, 2012
Record Details
This FDA Inspection record concerns Young Microbrush, LLC dba Microbrush International, with an inspection on October 22, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 22, 2012
- Product Type
- Devices
View Company Profile
ID · 5ec70243-2709-4146-aefb-85b2ab803141
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 804098
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.50(b)Supplier notification of changes
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