FDA 483 - Haleon US Inc. - February 14, 2013

This FDA Form 483 details significant observations from an inspection of a facility manufacturing various OTC and RX products, including Triaminic, Theraflu, Myoflex, Lamisil, Nupercainal, and Voltaren Gel. The inspection, which included a review of 1,066 consumer complaint investigations conducted by newly trained NCH investigators since October 15, 2012, revealed a pattern of deficiencies.

A critical finding was that 100% of nine randomly reviewed complaint investigations failed to address all potentially affected products. Specific issues included Triaminic Child Resistant Packaging/Cap failures, leaking/cracked containers, and appearance of crystals, with investigations not extending to similar products like Theraflu liquids. Voltaren Gel also had 141 complaints regarding illegible/missing lot/expiration dates, which were not associated with other products like Lamisil Cream. Investigations for these issues were often deficient, failing to extend to all affected lots and products, and were not always completed within the required 30 days.

The Quality Unit's oversight was found to be inadequate. Unplanned deviation trend reports for Q3 and Q4 2012 were not signed as reviewed, with 65% and 40% of deviations, respectively, not closed within 30 days. Investigation conclusions were not always supported by evidence, and known facts were omitted. Annual Product Reviews (APRs) for products like Volt