# FDA 483 - Dr. Reddy's Laboratories Limited CTO VI - November 17, 2014

Source: https://www.keypedia.com/records/483/dr-reddys-laboratories-limited-cto-vi/d171cc2f-d87c-49c9-b22a-bcb851894db0

> FDA 483 for Dr. Reddy's Laboratories Limited CTO VI on November 17, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories Limited CTO VI
- Inspection Date: 2014-11-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Dr. Reddy's Laboratories Ltd., an Active Pharmaceutical Ingredient manufacturer in Srikakulam District, Andhra Pradesh, was cited for significant deficiencies across multiple areas during an FDA inspection. Issues included widespread data integrity concerns in laboratory records and computerized systems, inadequate batch production and control records, and failures in document control and training record maintenance. Additionally, the firm was cited for insufficient process validation, inadequate laboratory investigations, and unsuitable water for API manufacturing, alongside poor washing and toilet facilities.

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## Related Officers

- [President](https://www.keypedia.com/people/peter-e-baker/c32eb848-de28-4725-80c9-ef8548d445bf)
- [USFDA/Director Division of International Drug Quality/CDER OC](https://www.keypedia.com/people/carmelo-rosa/cfc7c00c-9e11-485e-babe-f7726a7796a7)
- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

Company: https://www.keypedia.com/companies/dr-reddys-laboratories-limited-cto-vi/b0843338-2d7a-4525-9e2d-8a9ab428db2f

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