Drug factory · FDA FEI 3004395951

S. J. Smith Co., Inc.

4700 S South Clark, Mexico, MO, United States

Problems found, fixed voluntarily at FDA's last inspection, Jul 14, 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: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Nitrogen	Makes it	S. J. Smith Co., Inc.	11043-002
Oxygen	Makes it	S. J. Smith Co., Inc.	11043-001

Ended	Result	Program	Problems noted
Jul 14, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	3
Aug 18, 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.

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.
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.
Written procedures lacking for use of pesticides etc. 21 CFR 211.56(c)
Written procedures are lacking for the use of rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, and drug products.

Registered with FDA for: manufacture.