FDA 483 - Chesapeake Medical Products, Inc. - July 12, 2024

Chesapeake Medical Products, Inc. in Baltimore, MD, a medical device manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. The observations highlight a systemic failure to adhere to established procedures for nonconforming product control, complaint handling, vendor management, management review, and internal quality audits. These issues indicate a lack of effective quality system implementation and oversight.