FDA 483 - Maiden Biosciences - November 28, 2022

Maiden Biosciences, a medical device manufacturer in Gaithersburg, MD, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed a lack of a designated management representative for quality, absence of a quality policy and plan, and inadequate management review and internal audit procedures. Additionally, the firm failed to establish procedures for identifying training needs and maintaining employee training records.