The FDA slapped Midmark Corp. with a "significant" warning letter after an inspection of its Versailles, Ohio, headquarters last year.
The laundry list of violations from the watchdog agency focused primarily on manufacturing procedures and record-keeping issues related to the company’s steam sterilizer systems.
In one violation, deemed "significant" by the FDA, the health care device maker company failed to file a report after it realized the M11 steam sterilizer door could blow open during use.
"Please note that it has been established that events involving a malfunction of your firm’s M11 sterilizer, resulting in the door blowing open, is likely to cause or contribute to a death or serious injury if the malfunction were to reoccur," the FDA letter said.
Midmark also failed to maintain adequate records of contractors, suppliers and consultants who worked with the M11 system.
The federal watchdog agency also cited the company for failing to monitor production processes that ensure a device conforms to specifications.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.