www.fdanews.com/articles/168381-fda-tells-cook-to-fix-major-lapses-in-documenting-reworked-devices

FDA Tells Cook to Fix Major Lapses in Documenting Reworked Devices

November 7, 2014

Cook Medical is under FDA pressure to fix sweeping quality problems at its Indiana facility with the way it addressed more than 735,000 manufacturing noncomformances over a two-year period.

The agency found that the company’s problems were two-fold. Cook failed to adequately distinguish between products that were scrapped and those it reworked in response to a nonconformance. And in some cases it did not fully investigate the nonconformances to identify the causes of the problems.

For example, Cook scrapped 186,468 catheters for defects in the way the tips were bonded to the devices, but the devices were not matched with the nonconformances to ensure that all nonconforming devices were accounted for, according to a warning letter.

Meanwhile, process monitoring related to the scrapped catheters failed to trace the issues back to one of the plant’s 52 bonding machines, which the investigator noted were allowed to continue operating without revalidation testing or any other form of process monitoring.

The letter also criticizes Cook’s corrective and preventive action (CAPA) procedures. The plant manufactures vascular implants, intravascular catheters and related systems, and across all its product lines, Cook reported 500,000 scrapped in-process devices, but didn’t include that metric as a source of data that could trigger a CAPA investigation.

In separate weakness identified in its CAPA system, the investigator noted the firm tracked 171,000 production nonconformances, 236,000 scrapped products and 3,000 customer complaints to foreign matter making its way into the manufacturing process, but did not open a CAPA investigation.

Cook’s process validation also drew scrutiny as company officials couldn’t justify the performance qualification sample size for certain devices. And Cook’s sampling plan for the incoming inspection of woven graft materials was not based on a valid statistical rationale, the letter says. The procedure requires a sample size of one for each lot of woven graft materials, regardless of the lot size.

Every medical device manufacturer has to deal with nonconforming product, but many don’t know how. Learn how and prevent warning letters with Nonconforming Product Problems in Medical Devices.