CoreRX Inc. – FDA Inspection, Feb 26, 2026

Record Details

This FDA Inspection record concerns CoreRX Inc., with an inspection on February 26, 2026, issued by the Florida District Office, covering human drugs.

Company: CoreRX Inc.
Inspection Date: February 26, 2026
Product Type: Human Drugs
Office: Florida District Office
People: Kayla V. Sprague (FDA Associated Person)
Nicole E. Knowlton (FDA Associated Person)
Tammy T. Brown (Company Rep)

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ID · 956f34ef-816f-43f4-bdfd-ba4552b1e37e

Inspection Facts

Inspection number: 1304588
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.113(a)Procedures for non-sterile drug products
21 CFR 211.52Washing and toilet facilities are deficient
21 CFR 211.58Buildings not maintained in good state of repair
21 CFR 211.68(b)Computer control of master formula records
21 CFR 211.84(b)Representative Samples Criteria
21 CFR 211.84(d)(2)Component written specification

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Other FDA inspections of CoreRX Inc.

Date	Classification	Office	Project area
March 20, 2025	Not classified	Florida District Office	Vaccine, Allergenic, and Live Biotherapeutic Products
August 13, 2021	NAI	Center for Drug Evaluation and Research	Drug Quality Assurance
March 6, 2020	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
June 21, 2019	VAI	Florida District Office	Generic Drug Evaluation
June 14, 2019	Not classified	Florida District Office

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FDA Inspection

CoreRX Inc.February 26, 2026