FDA 483 - Apex Pharmacy, LLC - November 07, 2019

An FDA inspection conducted from November 4 to November 7, 2019, at Apex Pharmacy, LLC., a non-sterile drug producer in Beckley, WV, resulted in the issuance of a Form 483 due to significant observations. The inspection revealed the use of non-pharmaceutical grade components in the formulation of several non-sterile drug products, including Tretinoin Topical Cream and Omeprazole oral suspension. Furthermore, inspectors noted non-microbial contamination risks within the production area, specifically an analytical balance with compromised structural integrity that posed a potential for particulate shedding into drug components. Personnel engaged in processing were also observed not adhering to proper hygiene protocols, as the Pharmacist in Charge handled drug components without gloves. These observations indicate deviations from expected quality and control standards for drug compounding. Apex Pharmacy, LLC. is expected to address these deficiencies by implementing robust corrective actions to ensure the quality, safety, and integrity of their compounded drug products, aligning with regulatory requirements.