Drug factory · FDA FEI 1110624

Airgas Usa, LLC

2900 52Nd Ave, Hyattsville, MD, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 30, 2024.

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

3 drug inspections on record since 2009: 1 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, 11054-110

Ended	Result	Program	Problems noted
Sep 30, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	6
Jan 30, 2018	No problems found	Drug Quality Assurance	—
May 11, 2009	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.

Acceptance of drug products 21 CFR 211.160(b)(3)
Determinations of conformance to appropriate written specifications for acceptance are not made for drug products.
Acceptance criteria for sampling & testing 21 CFR 211.165(d)
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.
Written records kept in individual logs 21 CFR 211.182
Written records of major equipment use are not included in individual equipment logs.
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.
Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.

SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.
Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations.
Records of disposition of rejected material 21 CFR 211.184(e)
Records do not include the disposition of rejected drug product containers.

Registered with FDA for: manufacture.