Drug factory · FDA FEI 3004070098

Airgas Usa, LLC

305 Air Park Dr Ste 2, Fort Collins, CO, United States

Problems found, fixed voluntarily at FDA's last inspection, Jun 2, 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 2021: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

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

Ended	Result	Program	Problems noted
Jun 2, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	1
Mar 2, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	4

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

Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: manufacture.