FDA 483 - Ecometics, Inc.

During an inspection conducted from August 17 to September 7, 2018, the FDA issued a Form 483 to Ecometics, Inc., an Rx and OTC drug manufacturer located in Norwalk, CT. The observations, indicating potential violations of Current Good Manufacturing Practices (cGMP) under the Federal Food, Drug and Cosmetic Act, highlight several significant concerns.

Key issues include failures in preventing contamination, specifically regarding an unvalidated water system used for drug manufacturing and equipment cleaning, with inadequate procedures for microbial testing, filter changes, and sanitization. The firm also lacked proper temperature and humidity controls in production and storage areas, leading to drug products being held at excessively high temperatures. Repeated observations noted deficiencies in written procedures for equipment cleaning and maintenance, as well as unestablished accuracy of analytical test methods for product stability.

Additionally, Ecometics, Inc. failed to consistently follow its stability testing program, resulting in certain drug products lacking expiration dates supported by adequate data. The company also neglected to perform required microbiological testing for some OTC drug products. Further concerns involved reactive or absorptive manufacturing equipment surfaces, such as a stained tank lacking data to prevent leaching into products, and the poor state of repair of the facility, evidenced by water stains on the compounding area ceiling.

Ecometics, Inc. is expected to promptly review and implement comprehensive corrective and preventive actions to address all observations and ensure full compliance with regulatory requirements for drug manufacturing.