# FDA 483 - Dr. Reddy's Laboratories Limited (Unit II) - November 19, 2024

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited-unit-ii/270586ef-e74d-41e1-95e3-04a843954efa

> FDA 483 for Dr. Reddy's Laboratories Limited (Unit II) on November 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Limited (Unit II)
- Inspection Date: 2024-11-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Dr. Reddy's Laboratories Limited (Unit II) in Hyderabad, India, revealed significant deficiencies across multiple systems, including repeat observations for inadequate complaint investigations and computer system controls. The firm failed to maintain manufacturing processes in a validated state, exhibited poor quality control unit procedures, and lacked robust laboratory controls. These findings indicate a systemic failure to ensure the quality, purity, and compliance of Active Pharmaceutical Ingredients (APIs) destined for the US market.

## Related Documents

- [WARNING_LETTER - 2015-03-06](https://www.globalkeysolutions.net/records/warning_letter/dr-reddys-laboratories-limited-unit-ii/f32ac88e-3d0e-492c-96bf-fc45be17856f)
- [483 - 2019-07-12](https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited-unit-ii/4421091a-cc87-4530-9c0a-5a5de54b12e9)
- [483 - 2019-07-12](https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited-unit-ii/e127be34-a78b-472b-9cf1-761fe9d12d59)

## Related Officers

- [Yvins Dezan](https://www.globalkeysolutions.net/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-limited-unit-ii/8017cea4-be8d-4551-8eb7-f0f8cf4509da

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