Cook Medical has resolved a FDA warning letter that found fault with quality procedures at its medical device manufacturing plant in Bloomington, Indiana.
The FDA inspectors had criticized Cook for failing to establish a verifiable manufacturing process or procedures for investigating nonconforming products.
Cook responded to the warning letter by overhauling its quality management system and updating processes that predated modern technologies and regulatory requirements.
Cook Medical had a good regulatory record up to 2014. As a small, privately-owned company in the 1960s and 1970s, Cook established processes and procedures that ensured its products met customer expectations. When the FDA started overseeing the medical device industry years later, these ways of working stood Cook in good stead.
However, Cook and the FDA changed over the years. Cook grew from a small company whose work was directly overseen by its founder into a multinational manufacturer with sales topping $1 billion. In parallel, the FDA started to rethink what companies need to do to ensure quality.
The changes at Cook and the FDA converged in 2014 when inspectors from the agency visited the company’s Bloomington facility and left unimpressed. In a multi-page warning letter, the FDA listed seven areas in which Cook was failing to comply with regulations. The warning letter paints Cook as a company that failed to investigate quality deviations and validate materials and processes.
Four years later, Cook looks to have resolved the issues. The FDA is yet to update its public records but Cook says it received a close-out letter from the agency that resolves the warning letter. To get to this point, Cook has overhauled its quality management system. The changes have returned Cook to compliance but created problems for other parts of its business.
"As we’ve focused on resolving the warning letter and improving our company over the last four years, we have, at times, disappointed our customers. For example, adding new systems slowed our production capabilities, and we experienced shipment delays. We aren't finished yet, but our teams have worked hard to improve our delivery times, and we thank our customers for sticking with us," Cook president Pete Yonkman said in a statement.
The resolution of the warning letter is the latest sign that Cook has turned a corner. Cook conducted a series of recalls in 2015 and 2016 as reports of catheter tips splitting and fracturing mounted up, culminating in it voluntarily pulling all catheters featuring its Beacon Tip technology from the market. In April, Cook returned the products to the U.S. and Canadian markets.