Drug factory · FDA FEI 1518957

Nostrum Laboratories, Inc.

Bryan, Ohio, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

Problems found, fixed voluntarily at FDA's last inspection, Mar 13, 2025.

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

12 drug inspections on record since 2010: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Acetaminophen and Oxycodone	Makes it, tests it and packages it	Nostrum Laboratories, Inc.	29033-405
Codeine and Promethazine	Makes it, tests it and packages it	Nostrum Laboratories, Inc.	70408-185
Nitrofurantoin	Makes it, tests it and packages it	Nostrum Laboratories, Inc.	70408-239
Promethazine	Makes it, tests it and packages it	Nostrum Laboratories, Inc.	29033-500
Theophylline	Makes it, tests it and packages it	Nostrum Laboratories, Inc.	70408-644

FDA inspection history

Ended	Result	Program	Problems noted
Mar 13, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	4
Mar 13, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	4
Jan 11, 2018	No problems found	Drug Quality Assurance	—
Jan 11, 2018	No problems found	Drug Quality Assurance	—
Mar 15, 2016	No problems found	Drug Quality Assurance	—
Mar 15, 2016	No problems found	Drug Quality Assurance	—
Jun 28, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	8
Jun 28, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	8
Jul 21, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 21, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 16, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 16, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—

What inspectors wrote down

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

Mar 13, 2025 inspection

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Valid stability test methods 21 CFR 211.166(a)(3)
The written stability program for drug products does not include reliable, meaningful and specific test methods.
Valid stability test methods 21 CFR 211.166(a)(3)
The written stability program for drug products does not include reliable, meaningful and specific test methods.

Jun 28, 2013 inspection

Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.
Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.
Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.