483
Almitech, Inc.FDA 483 - Almitech, Inc. - March 30, 2018
Record Details
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.
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ID · 5f5ff164-b44c-431a-852b-132ac0aea0a0