Drug factory · FDA FEI 3004843240

American Welding & Gas, Inc.

100 READING AVE, Williamsport, PA, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 13, 2018.

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 2018: 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	American Welding & Gas, Inc.	44076-006
Oxygen	Makes it	American Welding & Gas, Inc.	44076-010

Ended	Result	Program	Problems noted
Sep 13, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	6

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

Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations.
Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection and checking of mechanical equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: manufacture.