WARNING LETTER
Globus Medical, Inc. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:
CMS# 685606
Globus Medical, Inc.
Valley Forge Business Center2560 General Armistead Avenue Audubon, PA 19403
Dates: February 15, 2024, through March 7, 2024
Inspection Issue(s):
These violations include, but are not limited to, the following:
- “The overarching concern is that the trend analysis you rely on to determine whether CAPAs should be initiated does not employ appropriate statistical methodology to detect recurring quality problems. Furthermore, there was no information provided on how your firm evaluated risk as a factor in determining whether to initiate a CAPA for this issue.”
- “Specifically, you did not follow your Product Complaint Procedure (SOP 8.3.1; Rev.T, U; Eff: 4/22/20, 1/19/22), which requires comprehensive complaint investigations. Moreover, this procedure did not include details on what constitutes a “comprehensive” investigation. “
- Failure to submit a report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2)
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
For more information, see the link below:
Globus Medical, Inc. – 685606 – 07/15/2024 | FDA
