Drug factory · FDA FEI 1750002

Airgas Usa, LLC

693 Long Acre Dr, Grand Junction, CO, United States

Problems found, fixed voluntarily at FDA's last inspection, Mar 4, 2022.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

2 drug inspections on record since 2017: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Nitrogen	Makes it	Airgas USA, LLC	11054-005, 11054-006
Oxygen	Makes it	Airgas USA, LLC	11054-009, 11054-010

Ended	Result	Program	Problems noted
Mar 4, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	2
Apr 26, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	3

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments and gauges is not done at suitable intervals in accordance with an established written program.
Laboratory equipment calibration records 21 CFR 211.194(d)
Laboratory records do not include complete records of the periodic calibration of laboratory gauges.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals in accordance with an established written program.
Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

Registered with FDA for: manufacture.