Chattem fails to report label changes.(Medical Devices)

Chattanooga, TN, company Chattem failed to report labeling changes made to its Icy Hot Heat Therapy patches after receiving at least 168 customer complaints of burns, skin irritation and skin removal injuries.

This deviation from FDA's medical device reporting (MDR) procedures was one of three observations on the 483 issued by agency investigators Wendy Blame and Natasha Mccants after their inspection of the company's facility Feb. 5-8, 2008.

The FDAers also cited Chattem for failing to report 15 complaints of injuries attributed to the company's patches as MDR reportable events. The injuries included second-degree burns, tearing of skin and skin removal that required wound care, blistering and scars left by burns, the 483 stated.

The inspection also revealed deficiencies in Chattem's CAPA procedures and implementation, Blame and Mccants wrote. They noted that the firm's CAPA procedures did not "include requirements for trend analysis of potential causes of nonconforming product or other quality problems, do not identify the sources that would be used as quality problem indicators, and do not address verification/validation. of CAPA to ensure that the actions are effective.

Chattem failed to initiate a CAPA in a timely manner to address a recurring problem, the inspectors wrote. "Two hundred complaints were received, 119 MDRs were reported and a correction action was implemented before a CAPA was generated in October 2007," the FDAers reported on the 483. Chattem, Inc., Chattanooga, TN, 2/5-8/08, Doc. 110126M, $4 plus retrieval

Checklist: Chattem, Inc.

[check] Label changes not submitted

[check] Unreported customer complaints

[check] CAPA procedure deficiencies

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