# FDA 483 - Calyx Chemicals & Pharmaceuticals Limited - November 04, 2019

Source: https://www.keypedia.com/records/483/calyx-chemicals-pharmaceuticals-limited/e6c38ac1-c189-46f8-a4ef-26fdd8cf44ad

> FDA 483 for Calyx Chemicals & Pharmaceuticals Limited on November 04, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Calyx Chemicals & Pharmaceuticals Limited
- Inspection Date: 2019-11-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: CALYX CHEMICALS AND PHARMACEUTICALS LTD. in Boisar, India, an API manufacturer, was inspected by the FDA from November 4-8, 2019. The inspection revealed significant deficiencies in the firm's quality unit, including failures related to stability data, validation protocol approvals, critical deviation investigations, and laboratory control records for sample management. These issues indicate a lack of robust quality oversight and data integrity for active pharmaceutical ingredients and intermediates.

## Related Officers

- [Carrie A. Hughes](https://www.keypedia.com/people/carrie-a-hughes/099d1128-0ba9-4e7a-a0d2-8c10083811c9)

Company: https://www.keypedia.com/companies/calyx-chemicals-pharmaceuticals-limited/e01c292e-7fb4-4afa-b74e-c1afc698d94d

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