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FDA Warns Dixon Investments for Missing Stability Testing and Poor Quality Oversight
The U.S. FDA issued a Warning Letter in October 2025 to Dixon Investments Inc. (dba ARI) following a March 2025 inspection that uncovered major CGMP violations. The agency found that the company lacked proper written procedures for production, process control, and product stability testing. No adequate program was in place to assess storage conditions or establish expiration dates, and the Quality Unit failed to ensure compliance with identity, strength, quality, and purity standards. FDA noted repeated failures to test sufficient drug batches as required by internal stability procedures, reflecting weak management oversight. Due to ongoing deficiencies, the agency warned it may reject new applications and export certificates until full remediation and CGMP compliance are verified through re-inspection.
27-10-2025
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