Dated August 12, the letter states that an FDA inspection of the facility from April 15 to May 13, 2008, found 12 separate violations of the agency's current good manufacturing practices (cGMPs) at the site, which manufactures and distributes the Chalfont St. Giles, U.K., vendor's Centricity PACS software. The alleged violations included:
- 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 as required by federal regulations
- Failure to establish and maintain adequate procedures for the identification, documentation, validation and 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 submit a written report (within 10 days) to FDA of all corrections or removals of devices initiated by the manufacturer
The warning letter goes on to state that the FDA has found GE's response to a number of the agency's concerns as being inadequate. The letter advises GE to "take prompt action to correct these deviations and to establish procedures to prevent their recurrence," and to submit a retrospective review of the agency's concerns by August 31.
Failure to correct the issues could result in seizure, injunction, or monetary penalties, the letter states. In addition, federal agencies will be notified of the warning letter and may take the information into account when awarding contracts, and premarket approval applications for GE class III devices related to the subject matter of the warning letter will not be approved until the violations are corrected.
In a statement, GE said it is "working aggressively" to address the issues raised in the letter.
"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," the statement said. "GE Healthcare 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."
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