# FDA 483 - Dr. Reddy's Laboratories Limited CTO VI - January 28, 2020

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-limited-cto-vi/8db56378-b1e2-4dea-a0e9-1546693fd707

> FDA 483 for Dr. Reddy's Laboratories Limited CTO VI on January 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Limited CTO VI
- Inspection Date: 2020-01-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Dr. Reddy's Laboratories Limited CTO Unit VI in Srikakulam District, India, received a Form 483 citing significant deficiencies in its manufacturing processes. The inspection revealed inadequate process validation, insufficient investigations into Out of Specification results, and poorly established cleaning validation procedures. Additionally, the firm failed to conduct trend analysis on APIs and demonstrated a lack of quality unit oversight for critical documents.

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## Related Officers

- [Aditi S. Thakur](https://www.keypedia.com/people/aditi-s-thakur/1c810eb2-86b0-4cae-b51d-43f3fb276ade)
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Company: https://www.keypedia.com/companies/dr-reddys-laboratories-limited-cto-vi/b0843338-2d7a-4525-9e2d-8a9ab428db2f

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