The FDA cited six devicemakers for problems found during inspections of their facilities, including inadequate validations, medical device reporting and investigations into complaints. Read More

The FDA found Anodyne Therapy’s validation and risk analyses were inadequate, and reports of radiation were not sent to the FDA, according to a 483 the firm received follow an agency inspection of its Oldsmar, Florida facility. Read More

Devicemaker Genicon failed to provide adequate resources for quality control operations to ensure that devices were designed and produced according to FDA regulations, according to a 15-item Form 483 the firm received following an inspection of its Winter Park, Florida facility. Read More

Failure to validate the design of its Specboard, which is used to localize suspect breast lesions during surgery, was among the quality system lapses the FDA observed during an inspection of Macbrud’s Miami, Florida facility. Read More

Specification developer Blue Belt Technologies failed to submit medical device reports (MDRs) for injuries associated with Smith & Nephew’s Navio tissue protector and bone pins, according to a Form 483 the firm received following an FDA inspection of its Pittsburgh, Pennsylvania facility. Read More

Inadequate design validation and risk analysis tripped up hearing aid maker Magnatone Hearing Aid Corp., during an FDA inspection of its Casselberry, Florida facility. Read More

Inadequate procedures for receiving, reviewing and evaluating complaints as well as other quality system shortfalls were observed during an FDA inspection of contract manufacturer LH Medical’s Fort Wayne, Indiana facility. Read More

Failure to validate reprocessing instructions for its Class II reusable menstrual cups and a host of other quality issues landed Dot International a seven-item Form 483 following an FDA inspection of its Evanston, Illinois facility. Read More

Process control procedures were found to be lax during an FDA inspection of Hudson Scientific’s Hudson, Michigan facility. Read More