Drug factory · FDA FEI 1717152

General Air Service & Supply Co.

6330 Colorado Blvd, Commerce City, CO, United States

Problems found, fixed voluntarily at FDA's last inspection, Mar 25, 2022.

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 2012: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Carbon Dioxide	Makes it	General Air Service & Supply Co.	21220-123, 21220-157
Helium	Makes it	General Air Service & Supply Co.	21220-200
Nitrogen	Makes it	General Air Service & Supply Co.	21220-120
Nitrous Oxide	Makes it	General Air Service & Supply Co.	21220-122
Oxygen	Makes it	General Air Service & Supply Co.	21220-119, 21220-130, 21220-152 +3

Ended	Result	Program	Problems noted
Mar 25, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	6
Dec 30, 2020	No problems found	Drug Quality Assurance	—
Jan 25, 2012	No problems found	Drug Quality Assurance	—

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

Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded and justified.
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.
Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals.
Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
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 written.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Registered with FDA for: manufacture.