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# Evi Labs CGMP Violations
- URL: https://www.fdaweb.com/evi-labs-cgmp-violations/
- Published: 2025-06-04T12:00:00.000Z
- Updated: 2026-09-14T15:13:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159300

A 1/9-1/15 FDA inspection at Evi Labs in Medley, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/evi-labs-llc-705846-05142025?ref=fdaweb.com) says the specific violations were:

- failure to have for each batch of drug product appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient;
- 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 establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and failure of the firm’s quality control unit to review and approve the procedures, including any changes; and
- failure 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 the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated.

FDA says Evi’s responses to the inspection observations were inadequate. It reminds the firm that it is responsible for the quality of the drugs it manufactures as a contractor regardless of any agreements in place with product owners. The agency recommends the company engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

Evi 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.