The FDA has sent GE Healthcare’s Integrated IT unit a warning letter about improper quality control standards, after a regulatory inspection of a GE facility that manufactures and distributes the software for its Centricity PACS.
The letter, dated Aug. 12, said that the Barrington, Ill., facility was in violation of 12 of the agency’s current good manufacturing practice requirements during an FDA inspection from April 15 to May 13.
In an emailed response, GE told Health Imaging News that it “has been working aggressively since the inspection to address the identified issues. GE Healthcare takes the warning letter very seriously, and is actively working on providing the information requested by FDA in the warning letter and on identifying further enhancements to the site's quality systems that may be appropriate.”
According to the FDA, the violations include the following:
- Failure to establish and maintain adequate procedures for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product and other sources of quality data to identify existing and potential causes of nonconforming product;
- Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation;
- Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot or batch of finished devices meets acceptance criteria;
- Failure to establish and maintain adequate procedures for the information that must be documented in a record of the investigation; and
- Failure to maintain adequate procedures for receiving, reviewing and evaluating complaints by a formally designated unit.
GE sent a letter in response to the FDA’s initial concerns; however, the agency said that company’s “response is inadequate.”
The agency said that GE now has 15 working days to send written notification of the violation corrections.
GE also said that its healthcare unit “is committed to providing its customers and their patients with products that are safe and effective for their intended uses, and to following FDA requirements and guidance on how this can be best achieved.”