Drug factory · FDA FEI 1818556

Flint Welding Supply Company

2201 Branch Rd, Flint, MI, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 12, 2015.

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 2011: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Nitrogen	Makes it	Flint Welding Supply Company	10412-0095
Oxygen	Makes it	Flint Welding Supply Company	10412-0001

Ended	Result	Program	Problems noted
Feb 12, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	3
Aug 4, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	2

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 gauges is not done at suitable intervals in accordance with an established written program.
Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing.

Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments and gauges is not done at suitable intervals in accordance with an established written program.
Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the receipt and approval of drug product containers.

Registered with FDA for: manufacture.