# FDA 483 - Dr. Reddy's Laboratories Limited - May 24, 2025

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited/b2f49475-3e13-4ffc-ab5d-d0c60fb7bf75

> FDA 483 for Dr. Reddy's Laboratories Limited on May 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Limited
- Inspection Date: 2025-05-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Dr. Reddy's Laboratories Limited – CTO 5, an API manufacturer in Telangana, India, revealed two significant observations. The firm failed to ensure equipment surfaces were maintained in good repair, as a streak was found on a reactor after line clearance and was not recorded. Additionally, electronic batch records were deficient, showing identical date and time stamps for both first and second person reviews, indicating a lack of proper documentation for quality-related activities.

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Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-limited/6e5a00e6-b2ca-4a53-9de3-c731fe0e8ab2

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8