# FDA 483 - Dr. Reddy's Laboratories Ltd. - February 24, 2020

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-ltd/1173293b-92c2-497b-8e97-a5a6507a2efe

> FDA 483 for Dr. Reddy's Laboratories Ltd. on February 24, 2020. 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: 2020-02-24
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Dr. Reddy's Laboratories Ltd in Medchal Malkajgiri District, Telangana, identified significant deficiencies in control procedures for manufacturing processes. The firm failed to establish adequate procedures to monitor output and validate the performance of processes that could cause variability in in-process material and drug product characteristics. This indicates a lack of robust process control and quality assurance.

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Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-ltd/5a4c4806-5444-4838-9cda-0b0da2f42221

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321