FDA 483 - Fragrance Manufacturing, Inc. dbs FMI - September 14, 2022

Fragrance Manufacturing, Inc. dba FMI in Allentown, PA, received a Form 483 with three repeat observations during an inspection from September 12-14, 2022. The firm was cited for significant deficiencies in its production and process controls, including a lack of process validation and hold time studies for OTC drug products. Additionally, the inspection revealed a failure to establish written procedures for equipment cleaning and maintenance, as well as a lack of equipment qualification and validation data.