adulterated within the meaning of Section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
There were 12 points of failure, although the letter rather explicitly states that the list is “not all-inclusive.” Most were addressed by GE, with most of the responses deemed “inadequate.” The letter contains chapter and verse of the regulations that were not satisfied, with examples thereof. There were significant problems with analysis of processes, records, etc. The procedure for implementing design changes was flawed. An MDR report was not submitted with 30 days of receiving information that a device had malfunctioned and could “cause or contribute to a death or serious injury if the malfunction were to recur.” Apparently, this refers to a a misdiagnosis which occurred after an incorrect patient jacket opened on a Centricity PACS workstation.
You should take prompt action to correct these deviations and to establish procedures to prevent their recurrence. Failure to promptly correct these deviations may result in FDA initiating regulatory action without further notice, including but not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System Regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office, in writing, within 15 working days of receipt of this letter of the specific steps you have taken to correct the violations, including:
• An explanation of your plan to prevent these violations from recurring.
• Any documentation of the corrective actions you have taken.
• An explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.
• A timetable for implementation of corrective actions. If they will not be completed within 15 working days, state the reason for the delay and the timetable for completing the corrective actions.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA-483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
I think they mean business. AuntMinnie reported GE’s response:
“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.”
I’m sure they will take care of these little problems.