FDA 483 - Millers of Wyckoff, Inc. - October 09, 2020

During an FDA inspection, a firm producing potent drugs like Progesterone and Testosterone from Active Pharmaceutical Ingredients (APIs) was cited for inadequate cleaning of utensils. Spatulas, jars, and glass beakers used for these potent drugs are not dedicated and are cleaned only with store-bought liquid dish detergent and potable water, lacking an agent to deactivate residual APIs, which could lead to cross-contamination. On September 17, 2020, Testosterone Topical 50mg/gm 15% Cream (Lot# 09172020@22), BIEST (b)(4)/Progesterone 20g/100mg (Lot# 09172020@15), and BIEST (b)(4)/Progesterone 2.5mg/125mg (Lot# 09172020@25) were observed being prepared in the non-sterile hazard production room using these methods.

Additionally, inadequate pressure differentials between air quality rooms were observed. Records of differential room pressures are insufficient, lacking quantitative values and failing to record pressure excursions. A cleanroom certification report from August 14, 2020, showed the Sterile Hazardous Room (ISO 7) pressure at -0.064” w.c., outside the specified acceptance range of (b)(4). Despite this out-of-specification reading,