FDA Inspection
The Medicines CompanyThe Medicines Company – FDA Inspection, Apr 17, 2015
Record Details
This FDA Inspection record concerns The Medicines Company, with an inspection on April 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Medicines Company
- Inspection Date
- April 17, 2015
- Product Type
- Devices
View Company Profile
ID · 8f06743d-fc24-4bba-b5e1-1196a6a33c75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 922782
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.22Quality audit - audit report review
- 21 CFR 820.20(a)Quality policy and objectives
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