Medical Device Daily Washington Editor

A November 2007 FDA inspection of the plant operated in Humacao, Puerto Rico, by C.R. Bard (Murray Hill, New Jersey), netted the firm a heavily detailed warning letter describing a series of miscues that may have left surgeons with the incorrectly sized surgical accessories and implants, including the Kugel line of hernia patches that were recalled in December 2005 and which are the subject of ongoing lawsuits.

Holly Glass, a spokeswoman for Bard, referred Medical Device Daily to a July 28 investor relations statement on the company's site that states that the company is facing "approximately 735 federal and 1,100 state lawsuits involving claims by approximately 1,940 plaintiffs" in addition to three "putative class actions" in connection with a December 2005 recall of the "Composix Kugel." The statement also notes that Bard "intends to fully implement corrective actions to address the concerns identified" in the warning letter, but cannot "give any assurances that FDA will be satisfied with its response to the warning letter or as to the expected date of resolution of matters included in the warning letter."

The lead citation – which was for lack of procedures for identifying products "during all stages of receipt, production, distribution and installation" – states that a procedure dealing with lot size "allowed excess finished units from up to three different batches of product to be added to another batch with a new lot number." According to FDA, "once the units were added to the new batch, your firm was unable to identify and trace the individual units back to their original lot numbers."

This finding was tied to an incident in which one lot of Bard's line of Kugel hernia patch kits ended up with patches with a different size monofilament, but the firm's internal investigation is said to have concluded "there was no impact on distributed products" because Bard was "able to segregate the affected units before they were distributed."

FDA states that this conclusion was unwarranted because of a similar complaint from March 2007 in which a product labeled "medium Ventralex" mesh, also a hernia patch, was in fact a small mesh. The warning letter also indicates that Bard "became aware of this situation only as a result of FDA's inspection." The agency states further that "we find it objectionable that after acknowledging the potential for mix-ups and deficiencies" related to the SOP in question, the corrective and preventive action report for the products with incorrect monofilament sizes "did not include an impact assessment for distributed products." The letter states that the company's responses dated March 18 and May 19, 2008, were inadequate and requests that the company provide updates on corrections.

The second citation notes an absence of procedures for control of non-conforming products, and lists two complaints regarding carotid artery shunts that were of an incorrect size. FDA states that the firm "took no further action" because it was deemed unlikely "that the known adverse effects of placing a bypass shunt would be increased by the use of a slightly larger device." The warning letter did not describe Bard's proposed corrections for this finding, but states that "they are inadequate" and observed "it seems that you do not appreciate the criticality of your mislabeling issues." FDA also cited the firm for similar problems in connection with the Vacora line of biopsy probes.

Toward the end of the warning letter, FDA acknowledges the firm's intent to create a "dedicated quality assurance group," hire a consultant and perform "other additional corrections." The warning letter was not posted at FDA's web site until last week despite bearing a date of July 22.

Steris warning cites RI plant

FDA tagged contract sterilizer Steris (Mentor, Ohio), for several problems in connection with several loads of products that were shipped from the company's plant in Coventry, Rhode Island, after undergoing sterilization for times and temperatures that were out of predetermined parameters. While the firm offered the agency two responses to the situation, the warning letter indicates FDA's dissatisfaction with those responses.

The warning letter states that Steris released part of one lot of an unspecified product for less than the prescribed duration (the parameters were redacted from the warning letter) at a higher temperature than indicated. Another load taken from a different lot, also sterilized with ethylene oxide, was in the autoclave for longer than the specified duration, but again, the parameters were redacted.

FDA states that Steris' July 16 response to the inspectional findings was inadequate because "your corrective actions did not address any product that was processed prior to the initiation" of the corrective/preventive action.

Another citation states that Steris sterilized a load with a software module that had not been approved. The company is said to have opened a corrective action to deal with the "server migration of unapproved cycles into the [redacted] software," but that at the time of the incident, Steris had not "initiate[d] any preventive action to ensure that this problem does not recur."

The company's second response drew no praise from FDA, which states that the company had not "provided any evidence that demonstrates that the process controller replacements will address the migration of unapproved ethylene oxide sterilization cycles."

In other instances, operators were said to have removed loads from autoclaves "without properly identifying the product," which in one instance led to the shipment of a load "19 hours before scheduled completion." That load, according to FDA, was shipped to the customer, although the letter does not address what became of the load after that point.

The company's director of corporate communication, Steve Norton, told MDD that the problems are restricted to the Steris Isomedix plant in Rhode Island and that "the issues being raised are due primarily to documentation and record-keeping practices" and have resulted in no quality or product problems. He said the plant has received no warning letters in the past.

LabCorp warned for homebrew Dx

A Sept. 29 FDA warning letter to Laboratory Corporation of America (LabCorp; Burlington, North Carolina), dealt specifically with the firm's web site, which FDA stated contained information about the OvaSure diagnostic. The warning letter indicated that the diagnostic "is a test that was designed, developed, and validated by investigators at Yale University (New Haven, Connecticut) and not by LabCorp." The warning letter went on to essentially state that the diagnostic was still under home-brew rules and as a consequence, LabCorp's description of the OvaSure at its web site violates regulations.