Drug factory · FDA FEI 1419818

Linde Gas & Equipment Inc.

12000 Roosevelt Rd, Hillside, IL, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 19, 2024.

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

What it does, for whom

Ended	Result	Program	Problems noted
Sep 19, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	2
Dec 4, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—

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

Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals.
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.