FDA 483 - Greco Gas, Inc. - April 05, 2024

Greco Gas, Inc., a medical gas manufacturer in Tarentum, PA, was cited for significant deficiencies across its operations. The inspection revealed widespread failures in product testing, raw material control, equipment calibration, quality control unit responsibilities, record-keeping, and employee training. These issues indicate a lack of adherence to Good Manufacturing Practices for medical gases like Oxygen USP and Nitrogen NF.