FDA 483 - American Distilling Inc. - April 26, 2022

An FDA inspection of American Distilling Inc., an OTC drug manufacturer in East Hampton, CT, revealed significant deficiencies across multiple areas. The firm failed to adhere to its written stability testing program and lacked adequate release testing for finished products, including microbiological testing. Additionally, the inspection found that written procedures for equipment cleaning and maintenance were not established or followed, and the quality control unit did not consistently perform timely reviews of facility records.