FDA 483 - Essentials Biotech Co, Ltd. - November 22, 2019

Essentials Biotech Co, Limited, a pharmaceutical OTC drug manufacturer in Suzhou, China, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written production and process controls, inadequate stability studies for drug product expiration dates, failure of the quality control unit to follow change control procedures, and insufficient written procedures and validation for equipment cleaning and maintenance. These issues indicate a broad lack of adherence to cGMP requirements.