FDA Inspection
Telea Electronic Engineering S.R.L.Telea Electronic Engineering S.R.L. – FDA Inspection, Jul 2, 2015
Record Details
This FDA Inspection record concerns Telea Electronic Engineering S.R.L., with an inspection on July 2, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 2, 2015
- Product Type
- Devices
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ID · 60ebff2b-14f4-462a-b188-4aca20c8ff64
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935011
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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