Creative Essences, Inc.

Warning LetterOpen

Mr. Alex D. Daliva President Creative Essences, Inc. 15320 Cornet Street Santa Fe Springs , CA 90670-5532 United StatesFEI 3006349554Issued Sep 25, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3006349554.

Violations7

Issue DateSep 25, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Creative Essences, Inc.
Location: Mr. Alex D. Daliva President Creative Essences, Inc. 15320 Cornet Street Santa Fe Springs , CA 90670-5532 United States
FEI Number: 3006349554
Country: United States
Issue Date: September 25, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Creative Essences, Inc., a manufacturer of over-the-counter drugs for oral, nasal, rectal, and topical use, failed to comply with Current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated. During a March 2025 inspection, the FDA identified that the company's quality unit failed to thoroughly investigate unexplained discrepancies and batch failures that did not meet specifications, violating 21 CFR 211.192. Additionally, the company manufactured an unapproved new drug product that was introduced into interstate commerce in violation of FDA approval requirements and was misbranded under federal law.

Creative Essences, Inc. FDA Warning Letter, September 25, 2025