Drug factory · FDA FEI 3002687909

Lampton Welding Supply Co Inc

109 S Broadway Blvd, Salina, KS, United States

Problems found, fixed voluntarily at FDA's last inspection, Dec 11, 2012.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

1 drug inspection on record since 2012: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Nitrogen	Makes it	Lampton Welding Supply Company, Inc	58356-002
Oxygen	Makes it	Lampton Welding Supply Company, Inc	58356-001

Ended	Result	Program	Problems noted
Dec 11, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	5

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

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.
Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not followed.
Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals in accordance with an established written program.
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.
Supervisor Training/Education/Experience 21 CFR 211.25(b)
Individuals responsible for supervising the manufacture of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.

Registered with FDA for: manufacture.