FDA 483 - One Way Drug DBA Partell Specialty Pharmacy - November 25, 2019

This FDA Form 483 document details observations from an inspection concerning the production of drug substances. The facility is cited for producing hazardous drugs without adequate containment, segregation, cleaning of work surfaces, and cleaning of utensils to prevent cross-contamination.

A key observation is the firm's failure to demonstrate that the (b)(4) and disposable germicidal wipes used by employees to clean (b)(4) hoods, equipment, and utensils between uses are capable of deactivating hazardous drug substances. This is critical because the (b)(4) hoods, equipment, and utensils are non-dedicated, meaning they are used for producing both hazardous and non-hazardous drug substances.

An example provided from the inspection on November 18, 2019, illustrates this issue. The facility produced a hazardous drug, (b)(4) g of Progesterone (b)(4) (Lot# (b)(4), Exp. 3/30/22) for compounding (b)(4) Progesterone 130 mg Capsules (Lot# 2091118@4.54). Immediately following this, in the same (b)(4) hood, a non-hazardous drug, (b)(4) g of Naltrexone Hydrochloride, USP (b)(4) (Lot# (b)(4), Exp 1/31/22) was dispensed for compounding (b)(4) Naltrex