Identifies several violations of the FD&C Act and QSR
On February 7, FDA issued a warning letter it had sent to MicroVention Costa Rica SRL on September 30, 2022. The company is a subsidiary of MicroVention Inc., a medical device company based in Tustin, California. The letter identified several violations of the Federal Food, Drug, and Cosmetic Act and the Medical Device Regulations.
Failure to validate manufacturing software
One of the violations mentioned in the letter was related to the company’s failure to adequately validate their software used in the manufacture of medical devices. The FDA noted that the company had not properly documented and validated the software used in their manufacturing processes, which could result in the production of defective devices.
Design Control noncompliance
The FDA also found that the company had failed to establish adequate procedures to control the design of their medical devices, including ensuring that design changes were properly evaluated, documented, and validated.
Complaint handling investigations
Another issue raised in the letter was the company’s failure to properly investigate complaints related to their medical devices. The FDA noted that the company had not adequately documented or investigated complaints related to device malfunctions, which could result in the failure to identify and address device issues.
General recordkeeping
The FDA also identified issues related to the company’s record-keeping practices. The letter noted that the company had failed to maintain complete and accurate device history records, as required by FDA regulations. The FDA found that the company had not properly documented the results of device inspections, tests, and evaluations.
Importance of compliance with regulations
The FDA’s warning letter to MicroVention Costa Rica SRL is a reminder of the importance of complying with FDA regulations for medical device manufacturing. The violations identified by the FDA can have serious consequences, including the production of defective devices that could harm patients.
Companies must ensure that they have adequate procedures in place to validate software, control the design of devices, investigate complaints, and maintain accurate records. By doing so, companies can help ensure that their devices are safe and effective for patients.
Link to the letter
Read the full Microvention Warning Letter.