FDA 483 - LiquidCapsule Manufacturing, LLC - July 03, 2025

The FDA conducted an inspection of LiquidCapsule Manufacturing, LLC, an OTC drug manufacturer located in Tampa, Florida, from June 25 to July 3, 2025. The inspection revealed several significant compliance issues under the regulatory framework governing drug manufacturing practices. Key observations included the lack of established written procedures for production and process controls to ensure drug products meet required identity, strength, purity, and quality standards. Specifically, the firm had not performed process validation for any OTC drug products since 2017, and equipment used in manufacturing had not been qualified or maintained properly. Additionally, the firm failed to validate the suitability of certain components and cleaning processes used in production.

The inspection also highlighted deficiencies in equipment cleaning and maintenance procedures, with no validation to ensure cleaning methods effectively remove residues from production equipment. Moreover, the firm lacked documentation supporting the cleaning methods and agents used.

The FDA requires LiquidCapsule Manufacturing, LLC to address these violations by implementing corrective actions, such as establishing comprehensive written procedures for production and process controls, validating equipment and cleaning processes, and ensuring ongoing compliance with regulatory standards. The firm is encouraged to discuss any objections or corrective actions with the FDA and submit relevant information to the agency.