FDA Flags Cleaning Validation Issues at Micro Orgo Chem

The FDA issued a Warning Letter to Micro Orgo Chem for cleaning validation deficiencies, posing a cross-contamination risk.

Key Findings

• SOPs for cleaning validation were not followed.
• No rinse/swab sample collection or analysis, despite procedural requirements.
• Equipment was dirty and poorly maintained.

Company Response & FDA's Stance

The company acknowledged the issues, recalled all active ingredients shipped to the U.S., and promised cleaning validation improvements. The FDA, however, demanded evidence of corrective actions, not just plans.

FDA Requirements

• Enhanced cleaning validation program, covering worst-case scenarios (high toxicity/potency, low solubility, etc.).
• Updated SOPs ensuring cleaning verification and validation.
• Comprehensive facility evaluation and CAPA plan for routine cleaning.
• GMP consultant engagement recommended.

A cleaning validation training course runs from May 5-7, 2025.

17-03-2025

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