# FDA 483 - Dr. Reddy's Laboratories Limited CTO VI - June 07, 2024

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-limited-cto-vi/0f8e7b96-e996-493f-abbe-c0625f1f10e5

> FDA 483 for Dr. Reddy's Laboratories Limited CTO VI on June 07, 2024. 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: 2024-06-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Dr. Reddy's Laboratories Limited CTO - Unit VI in Pydibhimavaram, India, revealed significant deficiencies across multiple areas of pharmaceutical manufacturing. The firm failed to adequately validate analytical methods for Active Pharmaceutical Ingredients (APIs) and ensure manufacturing processes remained in a validated state. Furthermore, out-of-specification investigations lacked scientific support and effective corrective actions, and the quality unit released API batches without completing all required tests.

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## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
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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