Medical Device Daily Washington Editor

The May 29 warning letter to UltraRad (West Berlin, New Jersey) included five deviations from the quality systems regulations (QSRs), including one that might strike the observer as ironic, given that the company makes medical record archiving systems. The firm was cited for failure to validate its use of two pieces of off-the-shelf software, and this and the other four QSR findings were all said to have been a repeat from a previous inspection during which a form 483 was issued. However, FDA's warning letter archive contained no other warnings for the firm.

The warning letter states that UltraRad's use of software known as HEAT Help Desk lacked a validation that included that "the details screen was functioning properly as intended." This function, the agency states, "is used to capture complaint details and complaint follow-up information, which would include corrective and preventative actions performed by your firm when service calls are determined to be CAPA issues."

The company is also said to have failed to validate its use of SharePoint, published by Microsoft (Redmond, Washington) in its quality system documents for document control and approval. The inspection disclosed that UltraRad possessed two different versions of a procedure covering corrective and preventive actions (CAPAs) and complaint procedures, but the software's document history function was said to lack a revision history.

The inspection, which ran from Feb. 23 to March 5, resulted in a citation for failure of CAPA procedures to require analysis of data other than customer complaint data. FDA also cited UltraRad for failure of the HEAT software to identify customer complaints that would qualify as a medical device report and for failure of quarterly audit reports to "include all areas of the quality system." The warning letter dealt with no company response to the inspectional findings.

At press time, the company had not responded to a call for comment.

Device history records trip Stat Medical

The April 17 warning letter to Stat Medical (Miami), a specifications developer, was peppered with citations in connection with the firm's device records, but the company should also consider a faster response to the 483 than it came up with for the inspection, which concluded Dec. 3, 2008. The firm's response was dated Feb. 3, a full two months and much longer than FDA will hereafter tolerate as indicated by FDA commissioner Margaret Hamburg's speech last week to the Food and Drug Law Institute (Washington).

Stat, which has developed specifications for a series of injection needles and lancets, was cited for lack of documentation "of the results of biocompatibility test(s)" for the Stat Super-Fine insulin pen needles in design history files (DHFs). Also said to be absent from the DHFs for the Super-Fine insulin pen needles was any documentation indicating that the needles, "which are intended for use with pen injector devices, are compatible with most pen injectors on the market." The warning letter did not cite the firm's response to this or several other findings in the warning letter other than to generally note that corrections had been promised, which FDA said would be "reviewed at a follow-up inspection at your facility."

FDA states in the warning that at the time of the inspection, the company lacked "documentation of [a] full ethylene oxide (EtO) sterilization study" for the insulin pen needles. The warning states further that the validation study for EtO sterilization was not exhaustively documented for empty chamber studies and biological indicator numerization, and that the records for the study included either insufficient or no data on temperature sensor calibration.

Purchasing controls arose during the course of the inspection, a common theme in FDA inspections dating back as far as early 2008. According to FDA, the company did not evaluate the ability of an unnamed supplier "to adequately maintain tooling" of Stat's clinical safety lancets and that Stat "did not document whatever evaluation ... it did perform."

FDA and the firm apparently had a different view of the requirements for medical device reports (MDRs) as indicated by a citation which states that the agency disagrees with a determination by the company that two failures of its safety lancets did not qualify for MDRs. The agency's view is that the failure of the lancets to retract "would be likely to cause or contribute to death or serious injury were this malfunction to recur."

The warning letter asserts that the insulin pen needle was "changed significantly through the addition of [redacted]" and that as a consequence, the firm had no 510(k) for the device. Stat is said to have promised on the last day of the inspection to suspend sales pending the filing of an application for clearance, promised for June 15. However, FDA inquired as to the company's intent regarding a withdrawal of units already on the market.

The company had not responded by deadline to calls for comment.

CI hit with warning pleads ignorance

As any police officer will tell you, "ignorance of the law is no excuse" in most instances, and FDA was not about to let Robert Phillips, MD, of Florence, South Carolina, off the hook with that kind of excuse.

The July 20 warning letter cited Phillips for lack of documentation that he obtained informed consent prior to enrolling two study subjects in 2006. Phillips' response was apparently that he had access only to the investigational device during the course of a procedure on the two subjects and was told during the procedure "that no standard ... devices were available." All the same, Phillips is said to have also claimed that he was certain "that all consents were obtained before any procedures were performed."

Device accountability proved to be nettlesome to Phillips. According to the warning letter, Phillips enrolled fewer subjects than would account for the devices he received in connection with an unspecified study. FDA states that the physician's explanation was "the sponsor did not inform you that device accountability was your responsibility," but and that all devices had been accounted for in a recent audit by the sponsor. Still, FDA asked Phillips for "your corrective and preventive actions to ensure you maintain accurate, complete, and current records of device accountability in the future." Phillips also indicated he was unaware of the necessity of filing annual reports with an institutional review board.

A Robert Phillips, MD, was associated with McLeod Cardiothoracic and Vascular Surgical Associates of Florence, but a spokeswoman for the physician practice told Medical Device Daily that the practice had not heard from Phillips "since the beginning of the year."

Mark McCarty, 703-268-5690; mark.mccarty@ahcmedia.com