FDA WARNING_LETTER - Kimberly-Clark Corporation - March 28, 2012

On March 20-28, 2012, an FDA inspection of a Roswell, Georgia firm manufacturing surgical gowns, patient warming systems, and feeding kits, identified violations. The firm's devices were deemed misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), for failing to furnish required material or information per section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806.

The significant violation was the failure to submit written reports to the FDA for device corrections or removals initiated to reduce a health risk, as required by 21 CFR 806.10(a)(1). Specific examples included five recalls between June 2010 and December 2010 for issues such as abrading surgical gowns, inadvertently shipped rejected gowns, patient warming system errors, and incorrect guidewire diameters in feeding kits. CDRH determined these should have been reported as they were intended to reduce a risk to health per 21 CFR 806.2(i)(2).

The firm's responses dated March 22, 2012, and April 13, 2012, were deemed adequate, as reports for each item were submitted, and the firm