FDA Inspection
European Medical Contract Mfg.European Medical Contract Mfg. – FDA Inspection, Sep 15, 2011
Record Details
This FDA Inspection record concerns European Medical Contract Mfg., with an inspection on September 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 15, 2011
- Product Type
- Devices
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ID · 4a4a544a-d462-4122-adc7-ff9b6949bafd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749456
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
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