FDA Inspection
Adams Meditech LLCAdams Meditech LLC – FDA Inspection, Apr 2, 2013
Record Details
This FDA Inspection record concerns Adams Meditech LLC, with an inspection on April 2, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Adams Meditech LLC
- Inspection Date
- April 2, 2013
- Product Type
- Devices
View Company Profile
ID · a15f35f8-4dea-4309-b67c-79a88dc5988e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 825586
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.50(a)(1)Documented evaluation
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