News Feature | November 5, 2014

FDA Warns Cook Medical On CAPA, Documentation Procedures

By Nick Otto


Bloomington, Ind.-based Cook Medical is on the FDA’s radar following a warning letter calling on the device maker to fix a slew of quality problems at its Indiana facility.

According to the letter, posted online recently by the FDA, the agency criticized the manufacturer’s corrective and preventive action (CAPA) procedures.

For example, Cook “scrapped 545,914 in-process medical devices across all device families” over a roughly two-year time period. However, the device maker failed to include that information in the analysis of quality data sources under the CAPA system.

In another issue, the FDA noted that “despite the on-going occurrence of foreign matter across all of [the] ... firm’s in-process and distributed devices,” the manufacturer failed to open a CAPA based on the following issues: 

  • 236,706 production units were scrapped due to foreign matter.
  • 171,581 production nonconformances were identified as having foreign matter.  
  • 3,066 complaints identified foreign matter in sterile devices.

Cook’s process validation also drew concern from FDA investigators after the agency said that Cook officials couldn’t justify the performance qualification sample size for a number of devices.

As an example, the FDA reported that Cook collected two samples from 30 lots with sizes ranging from 18 to 99 devices. “A sample selection of two per lot could not be traced back to valid statistical rationale and [the] ... firm’s protocol for collecting samples for analysis did not indicate how validation samples were selected,” according to the report. 

Finally, Cook’s processes for receiving materials were also chided by investigators. Between January and June of this year, the company accepted pre-bifurcated graft materials from raw suppliers even though all of the grafts required reworking for crotch stitching defects. Specifically, gauge and water permeability were not tested at incoming inspection or at any other point in the manufacturing process, according to the letter.

The warning is the result from an inspection by the FDA’s Detroit district office this past June and July.

The FDA said that responses in August and September of this year were inadequate due to the lack of corrective actions or documented evidence. In addition, the FDA said the device maker’s anticipated 2015 completion dates are “unacceptable.”