FDA 483 - Arnold Professional Pharmacy - September 05, 2018

On September 5, 2018, the FDA issued a Form 483 to Arnold Professional Pharmacy in Arnold, MD, following an inspection conducted from August 21 to September 5, 2018. The facility, identified by FEI Number 3012283530, is a producer of non-sterile drug products. The report was issued to Neil P. McGarvey, Pharmacist.

The sole observation noted during the inspection was the use of a non-pharmaceutical grade component in the formulation of a drug product. Specifically, the firm utilized [(b)(4)] water in the production of a released and distributed drug product, Rx #[(b)(6)], Amlodipine 1mg/mL, intended for a pediatric population. This indicates a potential quality system and manufacturing issue related to raw material control and adherence to appropriate component standards for drug products. The document does not provide further details on business or operational implications beyond the observation itself.