Drug factory · FDA FEI 3007049774

Atlas Welding Supply Company, Inc.

3530 Greensboro Ave, Tuscaloosa, AL, United States

Problems found, fixed voluntarily at FDA's last inspection, Oct 6, 2010.

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 2010: 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	Atlas Welding Supply Company, Inc.	51051-002
Oxygen	Makes it	Atlas Welding Supply Company, Inc.	51051-003

Ended	Result	Program	Problems noted
Oct 6, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	4

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

Procedures are written, and followed 21 CFR 211.130
Procedures designed to assure that correct labels are used for drug products are not followed.
Signature and checking of records -- 2 persons 21 CFR 211.186(a)
The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection, and checking of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.
Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.

Registered with FDA for: manufacture.