# FDA 483 - Dr. Reddy's Laboratories Ltd - October 25, 2019

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-ltd/c94c592f-e352-4715-99c3-c7675e634671

> FDA 483 for Dr. Reddy's Laboratories Ltd on October 25, 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: 2019-10-25
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Dr. Reddy's Laboratories Ltd CTO SEZ Process Unit-01, an API manufacturer, revealed significant deficiencies. Observations included inadequate investigations into potential root causes, insufficient evaluation of cleaning processes for non-dedicated equipment, and improper storage of production equipment. Additionally, the Quality Unit demonstrated a lack of oversight regarding manufacturing equipment.

## Related Officers

- [Dipesh K. Shah](https://www.globalkeysolutions.net/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-ltd/d2b12af8-d5d5-41a8-bb7a-b1acef5c5aa2

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd