GS Medical Packaging has received an FDA warning letter because it lacked several procedures, including an MDR procedure for its sterilization pouches.
The company’s post-inspection response was not adequate because it submitted a document, “Recall of Nonconforming Product,” that turned out to be its process for device recalls, rather than an MDR procedure, according to the June 12 letter posted online recently.
A late-January inspection also found the Mississauga, Ontario, company lacks procedures for control of new device designs or changes to devices. After the inspection, the company submitted a standard operating procedure for design control, but it was incomplete, the letter says. “The SOP does not address design transfer or the design history file,” the letter notes. “The SOP does not define the design and development activities and stages, lacks specifics with regard to how or where information will be captured (specific form title and or numbers) and does not define how often reviews will take place.”
The procedure was to be reviewed by management, but GS did not provide documentation of a review or indicate that it had conducted a retrospective review of all device designs to evaluate whether design control elements were present and documented.
The FDA also rapped GS for failure to establish procedures for conducting a particular test on its finished product lots. Such procedures should have discussed “how sampling is conducted; the number of samples per lot; test parameters and methods; acceptance criteria; procedures for when failing results are obtained; and documentation of test results,” the letter says. Post-inspection, the FDA acknowledged that GS had written and approved an SOP, but the procedure did not address the particular test.
Another citation notes the lack of written procedures specifying which documents and information to include in each device history record. And the company’s DHRs do not contain a final-release signature from the employee authorized to release each lot for distribution, the letter says.
While the company’s post-inspection response provided an SOP, it did not adequately address what is to be included in a DHR, the FDA maintains. Nor did it indicate which records must be included and/or call for a final-release signature. The response also lacked documentation of a management review of the SOP and did not indicate whether GS conducted a retrospective review of all device designs to evaluate whether all applicable records are in the DHR.