FDA 483 - Croda Europe Limited - September 12, 2025

Croda Europe Limited, an API manufacturer, received a Form 483 for multiple significant deficiencies observed during an FDA inspection. Key issues included inadequate investigations into laboratory and production discrepancies, a failure to ensure the continued effectiveness of cleaning procedures, and an insufficient risk assessment for water used in manufacturing. Additionally, the firm demonstrated poor document control and deficient Quality Unit oversight of electronic laboratory data, indicating systemic control weaknesses.