The US Food and Drug Administration (FDA) posted two warning letters on Monday that flagged a total of nine violations of good manufacturing practice (GMP) at California-based Total Thermal Imaging (TTI) and four violations of good laboratory practice (GLP) at an American Preclinical Services (APS) facility in Minneapolis.
TTI’s warning letter
comes after an FDA inspection of its website and brochures concluded that its Thermographic Business Package lacked the approval required to market uses that render the product a class III medical device and had been manufactured in violation of GMP requirements. The violations cite a range of procedural failures. These relate to design and purchasing control, acceptance activities, corrective and preventive actions, complaint handling, quality audits, training and management reviews.
The firm was also found to have been lacking quality system procedures related to remanufacturing activities. All devices were deeded misbranded over noncompliance with annual registration and listing requirements. The Thermographic Business Package device was also misbranded over medical device reporting (MDR) violations, including the firm’s failure to develop and implement MDR procedures.
The warning letter to TTI was posted along with an FDA safety communication that alerted
against the overall practice of marketing and promoting thermographic devices with unapproved or uncleared claims.
“Thermography is not an effective alternative to mammography and should not be used in place of mammography for breast cancer screening or diagnosis,” the safety communication noted, pointing to other warning letters in which facilities were instructed to immediately cease inappropriate claims.
FDA is “concerned that patients will rely on unapproved claims that thermography may be used as a sole screening device for breast cancer and not get screened with mammography, which is proven to save lives by detecting cancer and prompting patients to seek appropriate treatment,” FDA Commissioner Scott Gottlieb said
of the warning and the safety notice. “People who substitute thermography for mammography may miss the chance to detect breast cancer in its earliest and most treatable stages.’’
The other warning letter
to the APS facility in Minneapolis cites failures of the firm’s study director(s) and quality assurance unit to fulfill responsibilities. The former relates to a lack of corrective action “for animal deaths and unexpected study findings,” as well as failures to ensure protocols are followed as required and complete transfers to archives during or at the close of a study. The latter points situations in which the quality assurance unit should have identified observed failures regarding surgical technicians that performed anesthesia of animals, clinical pathology data and images of specimens.
APS was also cited over failures to adequately identify animals in animal-housing units, follow an SOP for analyzing water samples and ensure required labeling of reagents, storage and specimens.
The APS warning letter stems from the agency’s review of an inspection report prepared by FDA’s Office of Bioresearch Monitoring Operations, following investigators’ visit from March through April 2018. It also provides the agency’s reasoning for having deemed the firm’s response to its FDA Form 483 inadequate, requires the firm to respond with the specified documentation and calls for a conference call.