FDA 483 - Almitech, Inc. - March 30, 2018

Almitech, Inc. in Bellmore, NY, a manufacturer of dental implant systems, was inspected by the FDA. The inspection revealed significant deficiencies in design and process validation documentation, including a lack of shelf stability data for sterile dental implants and unapproved sterilization and sealing processes. Additionally, the firm failed to establish procedures for receiving and evaluating customer complaints.