FDA 483 - Fragrance Manufacturing, Inc. dbs FMI - April 24, 2026

Fragrance Manufacturing, Inc. in Allentown, PA, received two observations during an FDA inspection of its drug product manufacturing facility. The firm was cited for failing to conduct adequate ongoing stability testing to determine appropriate expiration dates for drug products. Additionally, deficiencies were noted in preventing contamination and mix-ups, including inadequate barriers and environmental controls in manufacturing and raw material sampling areas.