# FDA 483 - Dr. Reddy's Laboratories Ltd. - May 12, 2023

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-ltd/07b5462e-7e29-4956-b928-9ffe0e4f41df

> FDA 483 for Dr. Reddy's Laboratories Ltd. on May 12, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Ltd.
- Inspection Date: 2023-05-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Dr. Reddy's Laboratory, Unit-2, a drug manufacturer in Srikakulam, Andhra Pradesh, was cited for significant deficiencies in manufacturing equipment and laboratory controls. Observations included uninstalled and unqualified commercial packaging equipment, inadequate cleaning and maintenance of production equipment, and malfunctioning API dispensing balances. Additionally, the firm failed to validate FTIR release testing methods, perform required USP Performance Verification Tests, and establish pre-use verification procedures for laboratory instruments.

## Related Documents

- [483 - 2023-05-12](https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-ltd/d70d3ff3-a23c-4d1b-b3d0-b772ff1d78db)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)
- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/javier-vega/edd090c9-d867-4768-ac6a-6da459596d10)

Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-ltd/769ee88d-49d7-4a19-b97a-63ec71cb7114

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