German menstrual cup maker Meluna fell short on medical device reporting, complaint handling, and CAPA procedures, the FDA said in a six-item Form 483 following an inspection of the firm’s Haundorf facility.
The firm’s MDR procedure didn’t include an internal system for timely and effective identification and evaluation of events. For example, the firm’s device reporting SOP didn’t include adequate definitions and timelines to ensure timely submission of events subject to MDR requirements, the agency said.
The facility’s procedures for handling complaints were found lacking because they didn’t require information such as the name, address and phone number of the complainant, the date the complaint was received, the lot or serial number of the device and dates and results of investigations. During a review of complaint files, FDA inspectors noted that none of the complaints included any documentation of the MDR evaluation or any reply to the complainant.
CAPA procedures didn’t include appropriate statistical methodology to detect recurring quality problems, and the company did not investigate the cause of nonconformities. Complaints related to a chip on the rim of a menstrual cup were not correctly documented, investigators noted. For example, there was no record verifying the corrective action of increasing the time in the mold.
Process validation procedures were also not established, and the 483 noted that there were no records of the installation qualification, operational qualification or process qualification. In addition, the facility did not ensure equipment was routinely calibrated.
Read the Meluna Form 483 here: www.fdanews.com/09-06-18-meluna483.pdf.