Ceela Naturals – FDA 483, Aug 31, 2021

Ceela Naturals, a topical drug manufacturer in Louisville, KY, was cited for multiple deficiencies during an FDA inspection. Observations included failures in component identity testing for salicylic acid, inadequate laboratory controls for assay testing, and a lack of adherence to and approval of written production and process control procedures. Additionally, the firm failed to exercise strict control over drug product labeling operations.