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# CGMP, Other Violations at Dynamic Blending
- URL: https://www.fdaweb.com/cgmp-other-violations-at-dynamic-blending/
- Published: 2025-07-09T12:00:00.000Z
- Updated: 2026-09-14T15:16:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159473

A 12/3-12/6/2024 FDA inspection at the Dynamic Blending Specialists drug manufacturing facility in Vineyard, UT, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 6/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dynamic-blending-specialists-inc-701278-06182025?ref=fdaweb.com) says the specific violations were:

- failure to conduct at least one test to verify the identity of each component of a drug product, and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
- failure 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; and
- failure of the quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter also details unapproved new drug and misbranded drug violations stemming from an over-the-counter oral antiseptic drug product for which Dynamic does not have an application approved by FDA.

The agency reminds Dynamic that it is responsible for the quality of any drugs it produces as a contractor. It recommends that the firm engage a qualified consultant to perform a comprehensive audit of its operations and assist it in meeting CGMP requirements.

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