Drug factory · FDA FEI 3008585015

Steri-Pharma, LLC

429 S West Street, Syracuse, NY, United States

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

Serious problems, FDA action at FDA's last inspection, Aug 8, 2025.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

5 drug inspections on record since 2012: 1 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Cefuroxime	Makes it	WG Critical Care, LLC.	44567-712

Ended	Result	Program	Problems noted
Aug 8, 2025	Serious problems, FDA action	Drug Quality Assurance	3
Oct 4, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	2
Mar 24, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	1
Oct 10, 2014	No problems found	Drug Quality Assurance	—
Sep 20, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	1

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

Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
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.

Following/documenting laboratory controls 21 CFR 211.160(a)
Established specifications, test procedures and laboratory control mechanisms are not followed and documented at the time of performance.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

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.

Registered with FDA for: analysis; manufacture; pack.