Zimmer Biomet had hinted at a warning letter in an SEC filing last month but revealed little details about the exact nature of the deficiencies uncovered at the firm’s facility in Montreal, Canada.
Posted to the FDA’s website on July 11, the letter revealed numerous serious quality system deficiencies, including CAPA, complaint handling, supplier audits, medical device reporting and maintaining adequate records.
The Canadian facility is the principal location for Zimmer’s wholly owned subsidiary ORTHOsoft.
CAPA procedures were found to be lacking because the firms procedures didn’t describe how data would be analyzed to detect recurring quality problems. CAPA procedures didn’t include requirements to verify or validate that corrective and preventive actions were effective, nor did the firm’s procedures ensure that the quality unit was notified about nonconforming products.
FDA inspectors also took issue with the firm’s procedures for handling complaints. For example, eight out of 14 complaints reviewed didn’t include a medical device report determination, and the firm’s procedures didn’t require that complaints were handled in a timely manner.
The firm also had not established criteria for auditing suppliers, nor had it established procedures for its own internal quality audits, the warning letter said.
The letter also cited the firm for not reporting removals from the market within required timeframes.
The firm did not respond to a request for comment. Read the warning letter here: www.fdanews.com/07-15-16-ZimmerWL.pdf. — Tamra Sami