MDR, Validation Issues Top MicroAire Warning Letter

July 10, 2015

A Virginia maker of implants used in plastic surgery was slapped with a warning letter after an FDA inspection found flaws with the company’s validation and MDR reporting practices.

According to the letter, Charlottesville-based MicroAire Surgical Instruments failed to properly explain why it grouped its Ultratine and Endotine device lines together in validating a sterilization process.

The company provided the FDA with additional materials on the decision after investigators detailed the problem in a Form 483, but the response was inadequate because it didn’t include a thorough retrospective review of MicroAire’s rationale or documentation of independent sterilization validations for the devices.

MicroAire also hadn’t validated software used in production. The company’s response on this point was adequate and will be verified during a follow-up inspection, the warning letter says.

The FDA also dinged MicroAire for its adverse event reporting procedures. The company’s MDR policy didn’t define certain key terms such as “MDR reportable event” and failed to explain how to obtain an MDR reporting form.

The policy also gave no timeline for submitting supplemental reports and didn’t ensure that reports would be filed in a timely manner.

The Dec. 29, 2014, warning letter, which was posted online recently, followed an Aug. 11 to 22, 2014, inspection by the FDA’s Baltimore district office.

The company did not respond to a request for comment by press time.

Manufacturers and importers have until August 14, 2015, to begin submitting electronic medical device reports (eMDRs). There will be no more paper Form 3500As, no more MedWatch reports. 6 Steps to a Stress-Free eMDR Rollout will tell you everything you must know to transform your paper MDRs into electronic versions — and maintain FDA compliance.