# FDA 483 - Dr. Reddy's Laboratories Ltd. - October 29, 2021

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-ltd/bf6b9b32-c822-4d1b-a512-85f0c0d8a81c

> FDA 483 for Dr. Reddy's Laboratories Ltd. on October 29, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Ltd.
- Inspection Date: 2021-10-29
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Dr. Reddy's Laboratories Ltd. in Duvvada, India, a sterile drug manufacturer, was cited for significant deficiencies across its quality control unit, laboratory controls, environmental monitoring, and aseptic process validation. The inspection revealed a systemic lack of scientifically sound procedures, inadequate validation, and failure to follow established protocols. These issues indicate a high severity of non-compliance, impacting the assurance of sterile drug product quality and purity.

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## Related Officers

- [Rita Kabaso](https://www.keypedia.com/people/rita-kabaso/a8383d6d-b945-4edc-97a4-90944574835d)
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Company: https://www.keypedia.com/companies/dr-reddys-laboratories-ltd/3c6515a2-e42e-4803-ab0c-43955c67ee4f

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