# FDA 483 - Salicylates & Chemicals Private Ltd. - February 09, 2024

Source: https://www.keypedia.com/records/483/salicylates-chemicals-private-ltd/ebbb1718-e005-4c27-956c-ba8f29e37a5d

> FDA 483 for Salicylates & Chemicals Private Ltd. on February 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Salicylates & Chemicals Private Ltd.
- Inspection Date: 2024-02-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Salicylates & Chemicals Private Ltd., an API manufacturer in Hyderabad, India, was cited for significant quality system deficiencies. Observations included inadequate investigations into laboratory deviations, a lack of proper audit trail functions and data integrity controls for computerized systems, and the absence of method verification studies for USP pharmacopoeia analytical methods. These issues indicate a lack of robust quality control and data management practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/anthony-j-donato/a6dd6e14-529e-4b23-9b5f-02c88afb80ae)

Company: https://www.keypedia.com/companies/salicylates-chemicals-private-ltd/1cd58630-adea-4e76-a836-92943d571869

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