Drug factory · FDA FEI 3003585550

Victor Welding Supply Company

123 S Peoria Ave, Tulsa, OK, United States

Problems found, fixed voluntarily at FDA's last inspection, Nov 5, 2015.

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 2011: 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	Victor Welding Supply Company	66961-120
Oxygen	Makes it	Victor Welding Supply Company	66961-100

Ended	Result	Program	Problems noted
Nov 5, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	6
Jun 6, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	2
Sep 14, 2011	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.

Procedures Written and Followed 21 CFR 211.125(f)
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed.
Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of gauges and recording devices is not done at suitable intervals in accordance with an established written program.
Labeling Control Records and Label Copies 21 CFR 211.188(b)(8)
The batch production and control records are deficient in that they do not include copy of labeling.
Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to fully investigate errors that have occurred.
GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
Unauthorized Personnel in Limited Access Areas 21 CFR 211.28(c)
Unauthorized personnel have access to enter areas of the buildings and facilities designated as limited access areas.

Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
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.