FDA 483 - Airgas USA LLC - February 14, 2019

Airgas USA LLC in Assonet, MA, a medical gas filling facility, was cited for two observations during an FDA inspection. The firm failed to follow its written procedures for correcting entries on packaging control records and for documenting the receipt and examination of incoming bulk stock labels for Nitrogen NF products. These issues indicate deficiencies in quality control unit responsibilities and adherence to established documentation practices.