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# CGMP Violations at Absolutely Natural
- URL: https://www.fdaweb.com/cgmp-violations-at-absolutely-natural/
- Published: 2026-01-07T12:00:00.000Z
- Updated: 2026-09-14T15:30:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160443

A 4/22-4/24/2025 FDA inspection at the Absolutely Natural drug manufacturing facility in Melbourne, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/30/2025 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/absolutely-natural-715690-12302025?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 and document the accuracy, sensitivity, specificity, and reproducibility of the firm’s test methods; and
- failure to conduct at least one test to verify the identity of each component of a drug product.

The letter says the firm’s responses to the inspection observations were inadequate. FDA says Absolutely Natural’s quality systems are inadequate and recommends that it engage a qualified consultant to assist it in meeting CGMP requirements.

The agency notes that some of the company’s products may be regulated as cosmetics and cites new requirements under the 2022 Modernization of Cosmetics Regulation Act.

Absolutely Natural 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.