DDC Technologies, Inc. – FDA Inspection, Jun 28, 2019

Record Details

This FDA Inspection record concerns DDC Technologies, Inc., with an inspection on June 28, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company: DDC Technologies, Inc.
Inspection Date: June 28, 2019
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Andrew J. Garufi (Issuing Officer)

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ID · c20742aa-499b-415b-abd9-219a27ddee6c

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1094523
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 1002.13Failure to submit
21 CFR 820.184DHR - not or inadequately maintained
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.22Quality Audit/Reaudit - conducted
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ

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Other FDA inspections of DDC Technologies, Inc.

Date	Classification	Office	Project area
September 6, 2024	NAI	New York District Office	Postmarket Assurance: Medical Devices
October 22, 2021	VAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
January 8, 2020	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
December 7, 2017	VAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act
November 9, 2015	VAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act