Medical Device Daily Washington Editor

Most FDA investigators probably have a list of things that make them worry about a device maker's quality control efforts, one of which is surely the absence of qualified, dedicated quality control staff. Such was the case with two firms for whom the agency recently inked warning letters.

FDA's Jan. 18 warning letter to Omron Healthcare (Bannockburn, Illinois), listed 11 deviations from good manufacturing practices and four failures to comply with medical device reporting (MDR) requirements.

However, the most telling citation was that no members of Omron's management team was charged to supervise quality systems, a state of affairs that has persisted "since the previous quality manager left your firm" in January 2007.

The warning letter led with a citation for lack of corrective and preventive action (CAPA) procedures in connection with "six CAPAs from 2005." FDA said the company had no investigational plan for these and that the investigation disclosed "nine other CAPAs [that] have not yet been assigned for evaluation."

Another citation was described as a repeat from the previous inspection of July 2003. This citation was that the firm failed to investigate the failure of a blood pressure monitor that was "sent in for repair," but which was "switched out and a new one was sent out" to the customer. FDA said Omron's documents indicated "there was no investigation done" to determine the root cause of the failure, nor was "data forwarded to the foreign manufacturer." FDA addressed no proposed corrections for this citation.

Randy Kellogg, VP for marketing and product development at Omron, told Medical Device Daily that FDA is reviewing the company's response to the warning letter, adding "[w]e think we'll be fine after" FDA completes its review.

The Jan. 15 warning letter addressed to Hill-Rom (Batesville, Indiana), maker of hospital and therapeutic beds, cited the firm for lack of CAPA procedures in connection with a latching mechanism.

According to the warning letter, Hill-Rom determined that it had to redesign the latch for the side rail on the VersaCare line of hospital beds but that the field action had not covered all beds in the field as of July 25. FDA said that "there were no plans to notify consignees of the potential health hazard ... and no plans to perform a field correction of all affected units" despite "what you admit is 'an unacceptable failure rate in the field.'"

Hill-Rom's initial response dated July 2 (the inspection took place between May and June) was deemed inadequate due to a failure to fully implement the proposed fix, but an Oct. 2 update passed muster, according to the warning letter.

FDA also said that the company's procedures for reviewing complaints was inadequate, citing two complaints that were labeled "admit fix, not known." In one of these, the complaint was phoned in to the company and Hill-Rom personnel "provided some initial guidance, but failed to evaluate or investigate the malfunction." The company's response was that it would trend complaints initially resolved as "admit fix, not known," but FDA replied that the response included "no evidence ... that this trending is, in fact, occurring."

Lauren Green-Caldwell, a spokesperson for Hill-Rom, told MDD "We take regulatory matters very seriously and are very proactive should something arise."

She said that the issue had been addressed previously, including communication with customers. "We are reviewing our quality system" to bring it up to par, she said, adding that the company's approach "is to ensure safety for our customers and are working with FDA to ensure" product safety.

The Jan. 7 warning letter to Global Protection, a maker of condoms, led to some discussion between the agency and the company as to testing procedures, and the company's reference to external standards seems to have won the day.

Still the company took a hit from a citation that stated that Global "employs [only] one individual in the quality department," and that individual "does not have the education background, training or experience" to handle the job.

Global forwarded its Jan. 28 response to the warning letter to MDD, and the firm said that it is "hiring appropriate personnel to effectively implement and maintain our quality management responsibilities." Global said it has contacted regulatory consultant Emergo Group (Austin, Texas), which will review "any and all changes, non-conformities, customer complaints and corrective actions" for an unspecified period of time.

The first citation was that Global did not validate "the package seal integrity test used in final inspection of the product." FDA noted that the test in use at the time of the inspection deviated from standard operating procedures, and that "during demonstrated package integrity testing, your firm was not detecting leaks which were observed to be present by FDA personnel."

While Global's management representative was said to have "acknowledged the existence of 'bubble streams' and that they were similar to those observed during your own product testing," the company nonetheless "disagreed that the bubble streams constituted a leak." FDA said it was "very concerned with your validation issues and interpretation of test results."

Global's Jan. 28 response to the warning letter said that the firm has outsourced the package integrity testing function to Family Health International (FHI; Research Triangle Park, North Carolina). As for the packaging procedure itself, Global responded that it had validated "the new pouching material," which it did not name.

As for the question of the bubbles, the company's response stated that FHI is of the opinion the presence of bubbles per se does not constitute a sure-fire diagnosis of package leak. FHI cited standards promulgated by ASTM International (formerly the American Society for Testing and Materials, West Conshohocken, Pennsylvania), which say that testing with degassed water will draw bubbles "in most package seal tests" and that any bubbles of a quarter of an inch or less in diameter are "normal."

FHI's documentation also indicated that any package that "pillows" under such conditions is adequately sealed despite any observed emission of bubbles.