Life Sciences

GE warned for violating cGMPs

Device Regulation Alert: Safety, Compliance and Reimbursement News, October 6, 2008

General Electric’s (GE) Centricity Imaging and other Picture Archiving
and Communication System products were manufactured in facility that did not conform to Current Good Manufacturing Practices (cGMPs), according to an FDA warning letter.
 
The agency cited GE for failing to establish and maintain adequate procedures:
  • To identify existing and potential causes of nonconforming product
  • To identify, document, review, and approve design changes before their implementation
  • For finished device acceptance
  • For the information that must be documented in a record of the investigation
  • For receiving, reviewing, and evaluating complaints by a formally designated unit
 
In addition, GE did not submit a Medical Device Reporting report within 30 days of learning a device had or could malfunction, according to the letter. GE also allegedly failed to investigate and evaluate the cause of each event and did not submit a written report to the FDA of any correction or removal of a device.
 
The FDA said GE did not adequately respond to the first letter and recommended GE promptly correct these deviations and establish procedures to prevent their recurrence. The letter concerns GE’s plant in Barrington, IL.

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