FDA 483 - Arnold Professional Pharmacy - March 18, 2022

An FDA inspection conducted at Arnold Professional Pharmacy from March 7 to March 18, 2022, identified significant concerns regarding its production of non-sterile drug products. The observations, documented on an FDA Form 483, indicate practices that could lead to drug product contamination and adulteration, falling under the purview of the Federal Food, Drug and Cosmetic Act.

Key issues included inadequate segregation and cleaning protocols for beta-lactam drugs. The pharmacy was observed producing beta-lactam and non-beta-lactam products in the same general compounding room without dedicated spaces or sufficient decontamination steps, leading to potential cross-contamination through shared equipment.

Furthermore, non-microbial contamination was evident, with black-brown discoloration on a ceiling tile directly above active pharmaceutical ingredients. The facility's cleaning processes for reusable glassware and utensils were found to be insufficient, employing non-pharmaceutical grade soaps and leaving visible residue on equipment. The use of damaged equipment, specifically chipped spatulas with difficult-to-clean surfaces, also presented a contamination risk.

Arnold Professional Pharmacy is expected to promptly address these observations by implementing comprehensive corrective actions to ensure proper facility maintenance, dedicated equipment, validated cleaning procedures, and overall adherence to quality manufacturing standards to prevent product contamination.