FDA Inspection
Enztec LimitedEnztec Limited – FDA Inspection, Mar 14, 2013
Record Details
This FDA Inspection record concerns Enztec Limited, with an inspection on March 14, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Enztec Limited
- Inspection Date
- March 14, 2013
- Product Type
- Devices
View Company Profile
ID · b69dbed8-ce49-4d2f-82fa-3b9b58bd51a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 827705
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.184DHR content
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