FDA 483 - Elementis Specialties (India) Private Limited - September 20, 2024

Elementis Specialties (India) Private Limited received a Form 483 for significant deficiencies in its API manufacturing operations. Observations included a lack of process validation data for Active Pharmaceutical Ingredients, an inadequate long-term stability program with improper sample storage and representation, and insufficient controls over computer systems for laboratory records, leading to data integrity concerns. These issues indicate a moderate level of severity regarding quality control and data integrity.