Medical Device Daily Washington Editor

FDA is publishing far fewer warning letters these days than it did a decade ago, but the agency seems to have an appetite lately for letting some warnings acquire a little age before publishing them (Medical Device Daily, Aug. 22), and this week’s warning letter postings are no exception.

The March 2 warning letter to North American Medical (Marietta, Georgia), which makes spinal disc decompression devices, noted that the inspection took place between late September and early October 2006, and the company’s response to the inspectional findings was dated Nov. 9.

FDA cited North American for a pair of problems with its corrective and preventive action (CAPA) systems. One of these was a failure to verify the efficacy of corrective action for a malfunction of the decompression head in Accu-Spina disc decompression device. Among the verification lapses were those for changes to alignment of bearings, a replaced clutch and changes to the device’s software.

The warning letter noted that the firm’s Nov. 9 response was inadequate due to lack of “copies of the new CAPAs that were generated in response” to the inspectional findings.

The second finding under the CAPA heading was for failure to validate a change to a control board that was undertaken to deal with “vibra heat malfunctions.” As was the case with the previous citation, this finding included the note that the party that was responsible for approving corrective actions did not sign the corrective action paperwork.

FDA stated that the company did not handle complaints per standard operating procedures (SOPs) in two instances. In the first, North American made use of already-used complaint numbers to file new complaints and “the complaint information contained within the existing complaint numbers was removed” from the system and “filed separately.” The firm did not supply FDA with documentation as to its fix for this problem, hence the agency’s view that the company’s response was inadequate.

The agency cited the metro Atlanta company for failure to conduct an exhaustive design validation for the Da Vinci X 10, which is listed at the web site for Adagen Medical. The warning stated that North American personnel informed the FDA investigator that only software validation had been undertaken. The response to this finding, as was the case with most of North American’s responses, fell short due to inadequate documentation.

The seven-page warning letter contained another citation that addressed the “vibra heat” aspect of the Accu-Spina’s operation. According to FDA, the company’s file for a complaint filed in September 2006 regarding reports that the component was “too hot and it burns” did not include information on “the type of burn the patient experienced or any additional information regarding the incident.” The firm’s response to this finding after the inspection did not document North American’s investigation into the complaint, and FDA inquired as to how the company planned to address the MDR problems.

The Aug. 23 warning letter addressed to Potty MD (Knoxville, Tennessee) — which FDA described as a “specifications developer and distributor of enuresis (bedwetting) alarm devices” — led with a citation that the company “failed to implement quality system procedures prior to the announcement of the inspection” in June. FDA noted that “no devices should have been manufactured or distributed” without a quality system.

The warning letter stated that Potty had no procedures for corrective and preventive action (CAPA) prior to the date of inspection, despite having commenced operations in 2006. FDA redacted the number of complaints the company was said to have received since June 2006.

FDA stated that the firm “failed to appoint a management representative to ensure quality system (QS) requirements are met and to report to management” on the QS performance. The warning also highlighted a finding that suggested that the company saw its products as utterly benign, stating that the company “failed to develop, maintain or implement” medical device reporting procedures.

D. Preston Smith, MD, president of Potty, told Medical Device Daily, “we’ve responded to their letter and have a consultant” to help get operations into compliance both with FDA and ISO 13485 standards. Smith also said: “It would have been nice to know when we registered” about the compliance requirements for class II 510(k) exempt devices.