FDA EIR - Beiersdorf Manufacturing, LLC - November 15, 2019

An FDA routine surveillance inspection of Beiersdorf Manufacturing LLC's facility in Cleveland, TN, was conducted from November 13-15, 2019. This inspection, which focused on the manufacturing of over-the-counter (OTC) drug products such as Coppertone sunscreens, followed the company's acquisition of the Bayer Healthcare LLC Cleveland site in August 2019. The regulatory framework for this inspection was the Compliance Program Guidance Manual for Drug Manufacturing Inspections, ensuring compliance with current Good Manufacturing Practices (cGMP) under the Food, Drug & Cosmetic Act. The inspection comprehensively covered critical areas including Quality, Facilities & Equipment, Materials, Production, and Laboratory Control systems. Notably, the inspection concluded without the issuance of a Form FDA 483, "Inspectional Observations." This signifies that no significant deficiencies or violations requiring formal documented observations were identified by the investigators during the three-day review. Consequently, no specific regulatory actions were mandated by the FDA following this inspection, indicating that the facility was found to be operating in satisfactory compliance with applicable regulations for OTC drug manufacturing.