FDA 483 - Invahealth Inc. - December 15, 2021

An FDA inspection of Invahealth Inc. in Cranbury, NJ, revealed significant deficiencies in computer system controls, data integrity, and documentation practices for packaging and labeling operations. The firm failed to ensure proper controls over analytical data, adequately document packaging processes, and maintain complete batch production records. These issues indicate a lack of adherence to current good manufacturing practices.