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# ‘Significant’ CGMP Violations at Dunagin Pharmaceuticals
- URL: https://www.fdaweb.com/significant-cgmp-violations-at-dunagin-pharmaceuticals/
- Published: 2023-03-21T12:00:00.000Z
- Updated: 2026-09-14T18:20:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154027

An 8/29-9/2/22 FDA inspection at the drug manufacturing facility maintained by Dunagin Pharmaceuticals, doing business as Massco Dental, in Rogers, AR, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 2/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dunagin-pharmaceuticals-inc-dba-massco-dental-644335-02222023?ref=fdaweb.com) says specific violations were:

- failing to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups;
- failing to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality;
- failing to establish 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;
- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products; and
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.

The letter reminds Dunagin that it is responsible for the quality of the drugs it produces regardless of agreements in place with contract facilities. FDA recommends that the company retain a qualified consultant to assist it in meeting CGMP requirements.

FDA also says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it tests.

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