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# Dextrum Laboratories CGMP Violations
- URL: https://www.fdaweb.com/dextrum-laboratories-cgmp-violations/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:19:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156044

A 7/10-7/18/2023 FDA inspection at the Dextrum Laboratories drug manufacturing facility in Miami, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/7/2023 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dextrum-laboratories-inc-666442-12072023?ref=fdaweb.com) says specific violations were:

- failing to conduct at least one test to verify the identity of each component of a drug product;
- failing to conduct microbiological testing before using each lot of a component with potential for objectionable microbiological contamination in light of its intended use; and
- failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess.

The letter notes that FDA cited similar CGMP violations in previous inspections. “You proposed specific remediation for these observations in your responses,” it says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

FDA recommends that Dexdrum engage a qualified consultant to evaluate its operations, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of the firm’s corrective and preventive actions before it pursues resolution of its compliance status with FDA.

Dextrum was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.