Medinatura New Mexico, Inc.
FDA issued a warning letter to Medinatura New Mexico, Inc. (Albuquerque, NM) following a May 2025 inspection of their homeopathic drug manufacturing facility. The agency found significant CGMP violations including failure to adequately test incoming components for identity and purity (including hazardous ingredients linked to lethal poisoning incidents), an inadequate cleaning validation program that risked cross-contamination across multiple drug products, and a process validation program that had not been updated since 2007. FDA warned that failure to correct these violations could result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.
Required actions (5)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
A commitment to provide (b)(4) test results, as applicable, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products.
A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination (including, but not limited to, (b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related marketed drug product that could contain (b)(4), including customer notifications and product recalls for any contaminated lots.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
We strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm's compliance status with FDA.
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