Medical Device Daily Washington Editor
Product recalls and FDA inspections can trigger a lot of changes in the way a company does business, and the July 24 warning letter to the Gebauer Company (Cleveland), maker of Salivart, an artificial saliva product that FDA deems a device, said that the recipient had to outsource the production of its main product.
The warning letter said that Gebauer had declared a recall of a hydrofluorocarbon (HFC) product, which had been contaminated and was processed on the same equipment used to make the Salivart. According to FDA, Gebauer “is now contracting out the manufacture” of Salivart due to problems in complying with the Quality Systems regulations (QSRs).
Amy Paukovits, director of regulatory affairs for Gebauer, told Medical Device Daily that the company has no firm plans to resume in-house production of Salivart and will continue doing business with the contract manufacturer for the foreseeable future.
The warning letter said that the company did not include all documentation pertinent to its investigation into microbial contamination of Salivart, which had commenced Jan. 15. According to FDA, Gebauer’s investigation led it to take a look at the production of “Pain Ease medium,” the HFC product, which apparently was contaminated “with unacceptable levels of mold.”
The investigation began in March, but FDA said that the file into the HFC contamination “was not provided to the FDA investigator” during a March FDA audit and was not made known to the agency until a second review that began the following month.
FDA said that Gebauer “also did not provide [the investigator] any of the e-mails, memos or root cause analysis documents pertaining to the HFC products, all of which had January and February 2007 dates.”
The firm’s response to this finding was inadequate, FDA said, because it did not address “the steps your firm will take to ensure that the planned failure investigations are referenced or documented in your CAPA files.”
The agency cited Gebauer for lack of procedures to test heating, ventilation and air conditioning (HVAC) equipment for mold and other microbials, saying that the HVAC system “has been identified as the root cause” of the contamination. FDA also cited the company for failure to notify it concerning adverse events, including one instance in which a patient was in the hospital for three weeks.
The company’s responses to both findings were deemed sufficient.
Company spokesperson Paukovits told MDD that the company had responded successfully to two items that appeared on the 483 list of inspectional findings and that she had just completed the response to the warning letter.
The FDA letter indicated a recall of hydrofluorocarbon products, but Paukovits said the recall was of Salivart and was due to a cross-contamination at “very low levels, only in one lot” of Salivart. She also said that the CAPA finding “was a procedural issue” that the company rectified.
ECG lacks validation for Bluetooth
FDA sent a warning letter, dated July 30, to Pulse Biomedical (Norristown, Pennsylvania) that led with a citation for failure to “validate or otherwise verify” changes to the design of the company’s QRS electrocardiograph. According to the letter, “the design change from a standard USB interface to a Bluetooth (wireless) patient PC interface” was not tested and validated per the company’s standard operating procedures.
The letter said that the firm’s March 5 response to the 483 was insufficient because it included no evidence that the company had validated the design change and provided “no corrective or preventive action to be taken to address the problem of the design control procedure not being adhered to.”
The February inspection also disclosed that the company did not follow complaint-handling procedures in the case of a complaint, the nature of which was not specified in the letter. FDA stated that it found the company’s response lacking in that it did not document employee training on the proposed revision of complaint forms and did not document corrective actions for “the persistent practice of procedures not being followed.”
FDA also informed the company that the change to Bluetooth technology required the company to file a 510(k) application because the switch from USB connectivity constituted “a significant change.” At press time, Pulse Biomedical had not returned calls for comment.
Diabetic? Ask for bones, not McCoy
Just when researchers think they’re closing in on diabetes mellitus, other researchers find out that there’s more to the disease than commonly appreciated. Another lesson of this discovery is medical school students need not despair. There is still plenty to be discovered.
An article in the Aug. 10 edition of Cell says that the skeleton has endocrine effects in the form of osteocalcin, a protein involved in the formation of bone. According to the authors, led by Gerard Karsenty, MD, who chairs the department of genetics and development at Columbia University Medical Center (New York), osteocalcin increases the secretion of insulin and boosts insulin sensitivity simultaneously. However, the effect, like so many in mammalian physiology, is not direct, which explains why medical science had not stumbled on to this effect up to now.
“The discovery that our bones are responsible for regulating blood sugar in ways that were not known before completely changes our understanding of the function of the skeleton and uncovers a crucial aspect of energy metabolism,” Karsenty said. The paper shows that high levels of osteocalcin can ward off the development of Type 2 diabetes and obesity in mice.
Karsenty and others at Columbia had previously disclosed the effect of leptin, a hormone secreted by fat cells, on bone mass. Assuming a two-way street between the two tissue types, the researchers set out to figure out which cells in bones might communicate with fat cells. They discovered that osteocalcin enhances the function of pancreatic beta cells, which is seen as almost a sure way to treat Type 2 diabetes. Osteocalcin’s communication with fat tissue prompts the latter to release adipoectin, an agent that boosts insulin sensitivity.