# FDA 483 - Dr. Reddy's Laboratories Ltd. - August 20, 2019

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-ltd/a2da07ac-56ca-40ff-876a-e9eb2e6dd946

> FDA 483 for Dr. Reddy's Laboratories Ltd. on August 20, 2019. 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: 2019-08-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Dr. Reddy's Laboratories Ltd. in Duvvada, India, received an FDA Form 483 citing significant deficiencies in their manufacturing operations. The inspection revealed critical issues in quality control, aseptic processing, and environmental monitoring, indicating a lack of robust procedures to ensure sterile drug product manufacturing. These findings highlight serious concerns regarding product quality and patient safety.

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Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-ltd/3c6515a2-e42e-4803-ab0c-43955c67ee4f

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