FDA EIR - American Antibiotics, Inc. - March 28, 2013

An FDA inspection of American Antibiotics, Inc., a human beta-lactam antibiotic drug manufacturer located in Baltimore, MD, was conducted from March 4 to March 28, 2013. The inspection adhered to 21 CFR Parts 210 and 211, focusing on quality, production, laboratory controls, facilities and equipment, and packaging and labeling systems for their commercial Amoxicillin Capsules, USP. The inspection culminated in a five-item FDA Form 483, "Inspectional Observations." Key violations identified included the implementation of major changes to drug product impurity specifications without prior agency approval, insufficient training of production employees on operation-specific and quality assurance procedures, and a lack of scientifically sound specifications within laboratory controls to ensure drug product quality and purity following an API supplier change. Furthermore, deviations from written production and process control procedures were not recorded and justified, and labeling issuance control procedures were not consistently followed. Additional concerns discussed verbally with management involved the misclassification of deviations, inadequate validation for batch size alterations, reliance on only two months of accelerated stability data for a two-year expiry claim, the absence of formal complaint handling agreements with clients, and inadequate visual inspection during packaging operations. American Antibiotics management acknowledged the observations and committed to implementing corrective actions, including revising training protocols, updating complaint handling procedures, and enhancing packaging inspection processes. A written response to the 483 observations was promised within 15 business days.