Unreported Labeling Change Draws Warning Letter

Chattem failed to report a labeling change intended to reduce the risk of burns, skin removal and skin irritation with its Icy Hot Heat therapy patches, earning it a warning letter.

The labeling change came in response to more than 168 customer complaints, the letter said. And although these complaints are defined under the firm’s standard operating procedures (SOPs) as major complaints requiring a corrective and preventive action (CAPA), no CAPA was initiated to address them.

The FDA acknowledged Chattem has since submitted information on the labeling change and conducted a Class II recall in February. However, the company’s response is inadequate because it did not provide the agency with a revised recall SOP, the letter said.

Its response stated the procedure would be approved by late February, but the FDA had not received the procedure as of June 11, when the warning letter was sent. Further, Chattem did not provide documentation that personnel were adequately trained on its recall procedures.

Chattem’s response to the CAPA concerns appears to be adequate, the letter said; however, it did not provide documentation showing personnel have been adequately trained on the revised complaint and CAPA procedures.

The company said it is in the process of providing the FDA with the additional documentation requested in the letter, which was posted recently to the FDA website. It is available at www.fda.gov/foi/warning_letters/s6810c.pdf.