FDA 483 - Safetec Of America, Inc. - November 15, 2024

Safetec Of America, Inc. in Buffalo, NY, was inspected by the FDA, revealing significant issues with its quality control unit and laboratory controls. The firm failed to adhere to its own procedures for annual product reviews and purified water system monitoring. Additionally, the company did not test incoming Ethyl Alcohol for methanol limits, which is used in various OTC drug products.