Drug factory · FDA FEI 2913171

Airgas Usa, LLC

1592 Doolittle Dr, San Leandro, CA, United States

Problems found, fixed voluntarily at FDA's last inspection, Jun 4, 2015.

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

1 drug inspection on record since 2015: 0 with no problems, 1 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

Ended	Result	Program	Problems noted
Jun 4, 2015	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.

Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not established and followed for evaluations done at least annually and including provisions for a review of investigations conducted for each drug product.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Registered with FDA for: manufacture.