483
Safetec Of America, Inc.FDA 483 - Safetec Of America, Inc. - November 15, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 3f8f86e3-c84b-45ee-bb20-2c5b539a3699