FDA 483 - Elementis Specialties (India) Private Limited - September 20, 2024
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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.
- Inspection Date
- September 20, 2024
- Product Type
- Drugs
ID · 3809ea2a-04e0-4bd7-9ee6-c0923ef745c2