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

Source: https://www.keypedia.com/records/483/elementis-specialties-india-private-limited/3809ea2a-04e0-4bd7-9ee6-c0923ef745c2

> FDA 483 for Elementis Specialties (India) Private Limited on September 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elementis Specialties (India) Private Limited
- Inspection Date: 2024-09-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Robin P. Mathew](https://www.keypedia.com/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [Norman K. Clarke](https://www.keypedia.com/people/norman-k-clarke/bc348a18-ddb4-4b4d-a13a-047d190cf28f)

Company: https://www.keypedia.com/companies/elementis-specialties-india-private-limited/1c638e07-22cd-495f-a398-96269847dbf2

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1