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They concluded that many other factors besides trauma influence the shape of the nail, including constricting footwear, snug-fitting stockings and hosiery, inadequate or inappropriate pedicures, and heritable traits that can lead to incurvation of the nail border, with subsequent inflammation and infection

In response, Empower told the FDA that it was improving its manufacturing processes, but in 2018, the FDA investigators again noted in an inspection report that Empower was not adequately investigating problems with sterile drug quality