Drug factory · FDA FEI 2250062

Airgas Usa, LLC

1910 Old Cuthbert Rd, Cherry Hill, NJ, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 28, 2018.

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 2013: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Helium	Makes it	Airgas USA, LLC	11054-004
Helium and Oxygen	Makes it	Airgas USA, LLC	11054-032, 11054-041, 11054-042
Nitrogen	Makes it	Airgas USA, LLC	11054-006
Oxygen	Makes it	Airgas USA, LLC	11054-010

FDA inspection history

Ended	Result	Program	Problems noted
Sep 28, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	9
May 21, 2013	No problems found	Drug Quality Assurance	—

What inspectors wrote down

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

Sep 28, 2018 inspection

Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Distribution Recall System 21 CFR 211.150(b)
The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.
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.
Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product.
Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing and processing.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function and written procedures required by current good manufacturing practice regulations.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Registered with FDA for: manufacture.