Dixon Investments Inc. dba ARI

Warning LetterOpen

Mr. John Gordon Dixon President Dixon Investments Inc. dba ARI 2523 South McDonough Road Orchard Hill , GA 30266 United StatesFEI 1037559Issued Sep 17, 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 1037559.

Violations5

Issue DateSep 17, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Dixon Investments Inc. dba ARI
Location: Mr. John Gordon Dixon President Dixon Investments Inc. dba ARI 2523 South McDonough Road Orchard Hill , GA 30266 United States
FEI Number: 1037559
Country: United States
Issue Date: September 17, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Dixon Investments Inc. dba ARI, a drug manufacturer in Georgia, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection in March 2025, resulting in adulterated and unapproved drug products. The company's critical violations included failure to establish adequate written procedures for production and process control to ensure drug products met their identity, strength, quality, and purity standards, as well as failure to perform process validation for over-the-counter products. The manufactured drugs were also found to be misbranded under federal regulations, with the company introducing these non-compliant products into interstate commerce.

Dixon Investments Inc. dba ARI FDA Warning Letter, September 17, 2025