Failure to establish procedures for receiving, reviewing and evaluating complaints as well as failure to report complaints and other quality management issues landed Pfizer subsidiary PF Consumer Healthcare a Form 483 after an inspection of its Atlanta, Georgia plant.

FDA inspectors found that complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated or investigated.

Between Jan. 1, 2018 and Feb. 28, 2019, there were roughly 4,622 adverse events reported associated with the Thermacare pain product, and 1,199 product complaints and/or adverse events were not investigated.