FDA 483 - Expert Compounding Pharmacy - March 04, 2022

The FDA Form 483 details multiple deficiencies at a drug manufacturing facility. The firm produced hazardous drugs, specifically hormones, without adequate cleaning procedures for non-product dedicated utensils, failing to use a deactivating agent to prevent cross-contamination between hormone drug lots. This led to the release of numerous potentially cross-contaminated hormone drug products, including Testosterone and Estradiol/Estriol/Progesterone/Testosterone creams.

Significant non-microbial contamination was observed in production areas. The ceiling of the hormone drug manufacturing room had an air inlet vent visibly covered with dust, while drug products were being manufactured with air actively blowing from these vents. The general compounding area's ceiling, made of porous, uncleanable material, showed dirt and foreign material buildup above compounding stations, exposing drug components like Gabapentin capsules and Lidocaine/Tetracaine ointment to contamination during manufacturing.

The firm used non-pharmaceutical grade (b)(4) in non-sterile drug products without performing analytical or microbiological testing to ensure it met USP specifications. Furthermore, the facility failed to perform quality control testing on finished drug products for identity, strength, purity, and quality prior to lot release, and did not conduct analytical testing of incoming raw materials. This resulted in the distribution of numerous untested drug products and products made from untested components.

Batch production records were deficient, lacking documentation of actual weights and measurements of components and specific equipment used (e.g., analytical balances, mixing machines), leading to inadequate