FDA 483 - SUCO, Inc. - February 25, 2024

SUCO, Inc. in Silver Spring, MD, was inspected regarding its manufacturing of drug products, including STIFF 'N' SORE Cream and Gel. The inspection revealed significant deficiencies in production and process controls, including a lack of process validation, inadequate equipment qualification, and insufficient written procedures for manufacturing steps and change control. Additionally, the firm failed to conduct annual product reviews and maintain complete batch production records.