Drug factory · FDA FEI 2410853

United-Guardian, Inc.

230 Marcus Blvd, Hauppauge, NY, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 4, 2025.

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

6 drug inspections on record since 2010: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Anhydrous Citric Acid and Carbonate Ion and Gluconolactone	Makes it	United-Guardian, Inc.	0327-0012

Ended	Result	Program	Problems noted
Sep 4, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	5
Sep 5, 2024	Problems found, fixed voluntarily	Bioresearch Monitoring	1
Aug 2, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 16, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jul 22, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	3
Apr 7, 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.

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.
Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected.
Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each 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 and suitably located to facilitate operations for its cleaning and maintenance.
Written record not kept of program and validation data 21 CFR 211.68(b)
A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.

Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences.

Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not established and followed.
Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments, apparatus, gauges, and recording devices is not done at suitable intervals .

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
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 drug products conform to appropriate standards of identity, strength, quality and purity.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.

Registered with FDA for: manufacture.