As a result of the recalls of Bard® Composix® Kugel® Mesh Patches manufactured and distributed by Davol, Inc, the Food and Drug Administration conducted an inspection of the company’s facilities between January and March 2007. The inspection revealed Davol was deficient in meeting a number of Federal regulations for quality control in the manufacture of medical devices.
On April 24, 2007, FDA District Director Gail Costello sent a warning letter to Davol President Daniel LeFever requesting a meeting to discuss the corrective actions Davol had proposed in response to the violations found during the inspection.
The specific deficiencies cited in Director Costello’s letter were:
1. Failure to establish and maintain an adequate corrective and preventive action procedure which ensures identification of actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).
“For example, your firm initiated a class I recall in December, 2005 of all of your Extra Large Composix Kugel Hernia Patches due to breaks of the ring weld. In March, 2006, you expanded this class 1 recall to include other sizes of your Composix Kugel Hernia Patches due to three additional complaints of ring weld breaks. This second, expanded recall only included product manufactured prior to January 2004. Yet on March 31, 2006 and May 12, 2006, you received two additional complaints of ring breaks on large Composix Kugel Hernia Patches that were manufactured after January 2004. Your class 1 recall of the Composix Kugel Hernia Patches, manufactured after January 2004, was not initiated until January 10, 2007. “
2. Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained as required by 21 CFR 820.20.
“During the FDA inspection, we observed significant violations as they relate to a number of quality system regulations, including your corrective and preventive action (CAPA) controls as demonstrated by the above example. Similar deficiencies were previously brought to your attention in a FDA 483 dated February 7, 2006, after an FDA inspection on January 25, 2006. Recurring, serious deficiencies in this area point to a failure of your quality management system. “
“We acknowledge your response to the FDA-483 dated March 27, 2007 and your promised corrective actions. We believe that the changes you described will address the specific issues that were identified in the FDA-483. In your response to this Warning Letter, please address how your management will be addressing any additional changes in your global quality system that will prevent similar violations from recurring. We need to be assured that an effective quality system will be implemented immediately.”
3. Failure to document the implementation of corrective and preventive actions, as required by 21 CFR 820.100(b).
“For example, CAPA #Q6023, (opened on April 28, 2006 and closed on June 13, 2006), was initiated as a result of your class 1 recall of the Composix Kugel Hernia Patch due to ring weld breaks. This CAPA included the following specific action to be taken, “… establish complaint threshold limits for recoil ring break complaints & continue to monitor trends.” During the inspection, no documentation could be provided to our Investigator that demonstrated these limits had been established prior to closing of the CAPA.”
“We acknowledge your response to the FDA-483 that indicated the document was missing. You also provided a document dated March 12, 2007, that indicates a threshold limit of [redacted] has now been established. Your response goes on to describe that this threshold limit of [redacted] had always been in effect as evidenced by an undated document which you provide in appendix 3. We note that if this threshold limit had been in effect in 2006, i.e., upon receipt of at least six complaints from March 31, 2006 through August 29, 2006, your firm would have been required to initiate a corrective action much sooner.”
4. Failure to validate your device’s design to ensure that the device conforms to defined user needs and intended uses, as required by 21 CFR 820.30(g).
“For example, there was no documentation to demonstrate that design validation was performed on your Salute Reusable Fixation device. During the inspection, we observed a performance specification for your Salute Reusable Fixation device which states, “. . .the reusable assembly shall be capable of producing [redacted] Q Rings without compromising performance”. There was no documentation available to demonstrate that any testing was performed to ensure that the Salute Fixation device met this specification.”
“Your response to the FDA-483 states that validation was performed by [redacted] in 2002; however these files were archived and could not be located during the inspection. Your response does not address the failure of your design control system to ensure that the Salute Reusable Fixation device was evaluated and that it conformed to defined user needs and intended uses. We acknowledge your ongoing field action of your Salute Reusable Fixation device, FDA recall #Z-0374/0375-2007, due to numerous complaints and MDR’s of the device failing to function as intended.”
5. Failure of your firm to establish procedures to completely address the identification, documentation, evaluation, segregation, disposition and investigation of non-conforming product as required by 21 CFR 820.90(a).
“For example, procedures are lacking to ensure consistency in the handling and timing of activities from complaint receipt, complaint investigation, product assessment team meetings and remedial action plans to the determination of actual recall actions. In examining Davol’s numerous recalls of the Composix Kugel Hernia Patches and the Salute Reusable Fixation device, we observed quality system failures that resulted in delays in the ultimate disposition of non-conforming product.”
The FDA has not published Davol’s response to these violations, but it may be assumed the issues were resolved satisfactorily because no further enforcement actions against the company have been published.