FDA Inspection
Tena Group LLCTena Group LLC – FDA Inspection, Jun 29, 2016
Record Details
This FDA Inspection record concerns Tena Group LLC, with an inspection on June 29, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tena Group LLC
- Inspection Date
- June 29, 2016
- Product Type
- Devices
View Company Profile
ID · a3247229-9d26-4c13-93ef-e6c077fb4a66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 975469
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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