FDA Inspection
Auric Enterprises, Inc. D.B.A. DiackAuric Enterprises, Inc. D.B.A. Diack – FDA Inspection, Jun 17, 2015
Record Details
This FDA Inspection record concerns Auric Enterprises, Inc. D.B.A. Diack, with an inspection on June 17, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 17, 2015
- Product Type
- Devices
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ID · 9c3e243d-703e-4f3b-aa4b-f0b1f0a28d33
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 930509
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
13- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - 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 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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