FDA 483 - White House Pharmacy Inc. dba San Jose Compounding Pharmacy - September 14, 2018

The FDA Form 483 documents observations from an inspection, highlighting deficiencies in drug manufacturing practices. The facility produced beta-lactam drugs, highly potent drugs, and hazardous drugs without adequate containment, segregation, and cleaning to prevent cross-contamination.

Specifically, beta-lactam products were produced on the same day and in the same room (Lab Room) as non-beta lactam products, on a shared table within two feet. The cleaning agent used for work surfaces, (b)(4), and for dirty equipment, (b)(4) dish soap and water, were ineffective in deactivating beta-lactams.

Highly potent drugs, including Hydrocodone Bitartrate 10 MG capsules and Fentanyl Sorbitol Base (Veggie) 500 MCG Lollipops, were produced in the Lab Room on a shared table with limited space, alongside other patient-specific prescriptions. Cleaning agents (b)(4) for surfaces and (b)(4) for equipment were ineffective in removing highly potent residues.

Hazardous drugs, such as Testosterone and Progesterone, were produced in the Hazardous Room concurrently with other hazardous products. The firm's SOP 3.050, "Cleaning and Maintenance of the Non-Sterile Compounding Area," specifies cleaning solutions (b)(4) or (b)(4) and decontaminating solution (b)(4), which were found ineffective for deactivating hazardous drugs.

Additionally, the firm