The FDA, in late April, issued warning letters to three medical device firms citing serious CAPA and other violations at their facilities, including inadequate complaint response, quality testing, and verification of shipping and packaging methods to ensure product integrity and sterility.
Unetixs Vascular drew a warning over vascular diagnostic ultrasound systems manufactured at its North Kingstown, R.I. facility.
In a February inspection, the FDA found CAPA problems, including a failure to receive, review and evaluate complaints, and failure of a device, labeling or packaging to meet specifications. FDA inspectors noted 1,453 complaints going back to 2015 that were not opened or investigated. The firm also failed to establish and maintain procedures for changes to a specification, method, process or procedure, including documentation and verification.
Criticare Technologies, also in North Kingstown, R.I., was warned for CAPA issues, including failure to receive, review, and evaluate complaints, which numbered 1,385 since January 2016. These included six complaints reviewed at the time of inspection for which FDA said the firm failed to properly document, including information on whether a patient was harmed.
The agency said Criticare failed to inspect or test products from suppliers, including testing and inspection of subassemblies for its products.
Organ Recovery Systems received a warning for its Itasca, Ill. Facility, concerning devices used for flushing and cold storage of kidney, liver, and pancreas organs.
In a February inspection, the FDA inspectors found inadequate design documentation, including validation and identification of design methods; inadequate verification of packaging and shipping methods to ensure product protection and ability to meet functional specifications; and failure to ensure that received products, including bags to hold organ preservation solution, worked and met specifications for sterility. The firm’s responses to the findings were inadequate, FDA said.