FDA 483 - Arnold Professional Pharmacy - September 05, 2018

This FDA Form 483 was issued to Arnold Professional Pharmacy, located at 1460 Ritchie Hwy Ste 103, Arnold, MD 21012-2704, following an inspection conducted from August 21, 2018, to September 5, 2018. The firm is identified as 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 used [(b)(4)] water in the production of a released and distributed drug product, Rx #[(b)(6)], Amlodipine 1mg/mL, which was intended for a pediatric population. The document does not list any regulatory citations but highlights a quality system and manufacturing issue related to component quality. No other critical findings or deficiencies are detailed in this specific document. The business and operational implication is the need to address the use of non-pharmaceutical grade components to ensure compliance with drug product formulation standards.