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# Multiple Creative Essences Violations
- URL: https://www.fdaweb.com/multiple-creative-essences-violations/
- Published: 2025-10-07T12:00:00.000Z
- Updated: 2026-09-14T15:23:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159996

A 3/19-3/25 FDA inspection at the Creative Essences drug manufacturing facility in Santa Fe Springs, CA, found multiple violations, including significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/25 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/creative-essences-inc-710658-09252025?ref=fdaweb.com) says the specific violations were:

- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed;
- 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;
- 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 adequate written procedures for production and process controls designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
- failure of the firm’s quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter also lists unapproved new drug and misbranded drug violations. It says some of the firm’s products may be regulated as cosmetics that must comply with applicable statutory and regulatory requirements.

FDA recommends that Creative Essences engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

The company 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.