A Medical Device Daily
FDA's inspection of Inditherm Medical (Rotherham, UK) must have generated a hefty form 483, given the nine deviations from the quality systems regulation (QSR) detailed in the letter, but the agency may have done Inditherm a favor because the inspector discovered that the company had intended to market one of its patient warming devices for an unapproved use until the inspection cut the move short.
According to the June 10 warning letter, Inditherm management informed the investigator "that your firm plans to introduce" a device, the name of which was redacted, "to oncologists for the use of ... better exposure of patient veins during the injection of chemotherapy drugs." FDA informed the company that this constituted a new intended use and hence required a new 510(k) at the very least.
The heavily redacted warning letter also notes that Inditherm initiated a field correction without notifying FDA. The firm's Jan. 5 response to this finding fell short in FDA's eyes because it did not clarify "when to report a correction and removal" and did not "require a written justification should the event not be reportable."
Among the more routine QSR findings was that Inditherm was unable to document quality audits of the operation for 2007 and 2008, and FDA criticized the firm's failure to complete an audit "by 2009." The warning letter does not give the date of the inspection.
The warning letter also noted several problems with the company's medical device reporting (MDR) system, including that the MDR procedures did not spell out requirements for "timely and effective identification, communication and evaluation of events that may be subject to MDR requirements." The company's procedures are also said to have lacked requirements for "a standardized review process or procedure for determining whether an event meets the criteria for MDR reportability." FDA deemed Inditherm's response to this and several other MDR finding inadequate because the company did not provide "a revised procedure which meets all the MDR requirements."
Spanish firm busted for avoiding FDA
Some companies get warning letters for problems with their failure to comply with good manufacturing practices, and some firms working outside the U.S. find their products detained for those problems. But Madespa (Toledo, Spain), maker of dental amalgams and other items and supplies, was the recipient of an Oct. 2, 2008, warning letter that included a citation for failing to notify the agency that it was doing business in the U.S.
FDA waited until last week to post the warning letter, which cited the company for a variety of GMP lapses, including failing to document changes to device design, including a failure to include in the design review team an employee who is "without direct responsibility for the design stage being reviewed." The warning letter also noted that the company could offer no documentation of supplier audits during a period of time that was redacted from the warning letter.
One of the citations that would probably draw a rebuke from any inspecting authority was that the company's "processing records and [device history records] contained errors that were not crossed out and initialed by the employee responsible for performing the task."
Given the totality of the picture, FDA warned Madespa that its products may be detained and that "we may need to re-inspect your facility to verify that appropriate corrections have been made." The agency also informed the company that its products were effectively misbranded because "you did not notify the agency of your intent to introduce the device into commercial distribution" in the U.S. or its territories without first notifying the agency.
Condom maker hit with second warning
Even condom makers get a looking over by FDA, as Dongkuk Techco Rubber Industries (Penang, Malaysia) discovered, receiving a second warning letter in 10 years. While the first warning, dated Aug. 18, 1999, was a relatively brief affair and suggestive of an inaugural inspection, the second warning was more comprehensive and indicated that the company failed to take the first warning letter to heart.
The first warning letter was devoted largely to a lack of procedures for changes to the design of the company's condoms, and made note of a clearance issued by the agency dated May 17, 1999. That earlier warning letter nonetheless asserted "this clearance does not exempt you from design control requirements or any other aspects of good manufacturing practices."
All the same, the Dec. 30, 2008, warning cited Dongkuk for failing to follow its own design change control procedures in connection with one of the firm's condoms. Other design citations include those for failure to document that design output matched design input "with respect to dimensions, bursting volume and pressure, tensile properties [and] seal integrity."
The company's quality audit procedures attracted some attention as well, including a very conspicuous citation for "a contract review audit for 2006 [which] was conducted by the general manager, who has overall responsibility for the matters audited."
FDA informed the company that its condoms would be detained pending a response to the warning letter and that a follow-up inspection may be required to lift the detention.