FDA 483 - Fragrance Manufacturing, Inc. dbs FMI - September 14, 2022
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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.
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ID · f422ea9c-5a1d-4e0b-b556-d85e472098b5