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

A recent FDA inspection of Fragrance Manufacturing, Inc. (FMI) dba FMI, located in Allentown, PA, was conducted from September 12-14, 2022. This was a pre-announced drug surveillance Current Good Manufacturing Practice (CGMP) inspection, performed under CPGM 7356.002, focusing on their manufacturing of non-sterile liquid and ointment drug products. The inspection revealed significant deficiencies, resulting in a three-item Form FDA-483, Inspectional Observations, issued to CEO/President Mr. Kevin Rhodes.

The main violations identified were: 1) a lack of written procedures for production and process controls to ensure drug product identity, strength, quality, and purity, specifically regarding process validation and hold time studies (a repeat observation, 21 CFR 211.100(a)); 2) no established written procedures for the cleaning and maintenance of equipment, including a failure to perform cleaning validations or verifications (a repeat observation, 21 CFR 211.67(b)); and 3) the absence of written records and validation data for equipment qualification (installation, operation, and performance), also a repeat observation (21 CFR 211.68(b)). The firm utilizes non-dedicated equipment for both FDA-regulated and non-FDA products.

Management acknowledged these observations and committed to undertaking corrective actions. They indicated they would provide a written response to the FDA within 15 working days following the inspection's close. Additionally, verbal recommendations were made regarding temperature mapping and monitoring in storage areas, and proper equipment storage to prevent damage.