Dixon Investments Inc – FDA 483, Mar 11, 2025
Dixon Investments Inc, a drug manufacturer in Orchard Hill, GA, was inspected by the FDA and received a Form 483 with seven observations. The inspection revealed significant deficiencies in quality control unit procedures, batch record completeness, stability testing, cleaning and process validation, annual product reviews, computer system controls, and cGMP employee training. Several issues, including process validation, were noted as repeat observations, indicating persistent non-compliance.
- Office
- Atlanta District Office
- Person
ID · 58bab81c-91b1-4be5-ab36-d85a318f0160
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