July 14, 2015
It’s been a little while since we checked the FDA’s outgoing mail tray to find out what inspectors are looking for – and often finding. This occurred during their visits in the first half of 2015.
AG Industries Cited for MDR and CAPA Failures
We begin with a substantial June 12 letter to AG Industries in St. Louis. It hit for a number of alleged 820-related shortcomings, including:
- Failure to promptly review, evaluate, and investigate complaints related to a Medical Device Report (MDR) review and file an MDR with the agency for what it deemed one of perhaps several “serious complaints.” FDA found AG’s response “inadequate” because the firm labeled the incident to be not life-threatening, where the agency clearly has some doubts.
- Failure to adequately validate a process according to established procedures means that its results can’t be verified by additional testing.
- Additionally, failure to establish adequate procedures for the acceptance of finished medical devices.
The FDA reports that approximately ten percent of the nearly 210 complaints the firm has received since early 2013 remain open. Specifically, it called out a complaint that AG received in August 2013.
Note: Throughout the letter, FDA says AG’s characterization of its CAPA problem as minor “appears inappropriate.”
Insulet Corporation Warned Over cGMP and Quality System Violations
Insulet Corporation, the manufacturer of the Insulin Management System, had a relatively easier time of it in a June 5 letter. The FDA hit the firm for devices it alleges are adulterated. This is because the methods used in, or controls of, the manufacture, packing, storage, or installation don’t meet FDA good manufacturing practice (cGMP) requirements. These are part of its Quality System regulation.
The FDA responded that the firm’s April 16 submission was not adequate. And advised the firm that “regulatory action” could be initiated. Without further notice. Unless the Massachusetts-based firm takes prompt action to correct the violations FDA alleges in the warning letter.
Nephros Cited for Supplier Evaluation and Complaint Investigation Issues
In New Jersey, the FDA called out Ultrafiler-maker Nephros for alleged failure to document the evaluation of its suppliers. Like Insulet, the firm was also criticized in the May 27 letter for not including the required information on complaint investigations.
Thorn Dental Laboratory Faces Multiple CAPA and Misbranding Violations
Bothell, Washington-based Thorn Dental Laboratory LLC was challenged in a June 2 letter on a number of CAPA-related fronts, including:
- An inability to produce CAPA procedures for review during the inspectors’ series of inspections in February.
- Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
- Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specific requirements, such as failing to maintain adequate documentation of suppliers, contractors, and consultants.
- Additionally, failure to establish and maintain procedures for accepting finished devices.
- Misbranding its anti-snoring/sleep apnea devices.
Insightra Medical Cited for MDR Shortcomings and Facility Control Issues
Our final letter in this go-round’s review focused on Irvine, California-based Insightra Medical, maker of catheters and hernia implants. The agency stated that the firm’s devices are adulterated because Insightra failed to control its facilities in terms of manufacture, packaging, storage, or installation.
Insightra Medical Cited for MDR Shortcomings and Facility Control Issues
Insightra was hit with a number of MDR shortcomings. These include the failure to establish internal systems providing for “timely transmission” of complete medical device reports.
