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

On August 12, 2024, the FDA issued Warning Letter #683090 to Greco Gas, Inc., following an inspection from March 27 to April 5, 2024, at their Tarentum, PA facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products, including Oxygen, USP and Nitrogen, NF, adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to conduct identity testing for components and validate supplier COAs (21 CFR 211.84(d)(1) and 211.84(d)(2)).** The firm relied on supplier COAs without validation and did not perform identity testing for each component lot. 2. **Failure to conduct adequate finished product testing (21 CFR 211.165(a)).** Medical gases were released without full testing for impurities, identity, and strength of active ingredients. 3. **Failure to routinely calibrate equipment (21 CFR 211.68(a)).** Numerous pieces of equipment, including pressure/vacuum gauges and oxygen analyzers, were not calibrated at required intervals. 4. **Failure to thoroughly investigate discrepancies (21 CFR 211.192).** Recurrent container