# FDA 483 - Dr. Reddy's Laboratories Limited CTO VI - June 07, 2024

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-limited-cto-vi/b2260347-a826-4850-b75a-2bba503efa5e

> FDA 483 for Dr. Reddy's Laboratories Limited CTO VI on June 07, 2024. Product: Biologics. 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: 2024-06-07
- Product Type: Biologics
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: The FDA Form 483 details significant deficiencies at a facility manufacturing Active Pharmaceutical Ingredients (APIs) with active US Drug Master Files (DMFs), distributed to customers and currently in the market.

**Key Violations and Observations:**

1.  **Analytical Method Validation:** Analytical methods for final API testing, including in-house and compendial methods, were not validated or verified under actual conditions of use. This includes methods for water content, residual API quantitation, and GC residual solvent analysis. A customer complaint (200428799) identified an OOS for water content in a released API batch (Batch#) due to a non-validated method. An unknown peak, characterized as [specific impurity], was identified in approximately [number] batches from 2020-2023 during GC residual solvent analysis. Despite establishing an internal control limit and developing an ion chromatography method (01May2022), approximately [number] shipped batches, including those for US marketed products, were not retested using the validated procedure.

2.  **Process Validation and Control:** Manufacturing processes are not maintained in a validated state. From May 2022 to January 2024, 17 OOS results for [specific impurity] in API led to reprocessing of all 17 batches, including approximately [number] for US marketed products. Hypothesized root causes included humidity control and material hold times

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## Related Officers

- [Joseph A. Piechocki](https://www.globalkeysolutions.net/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
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Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-limited-cto-vi/b0843338-2d7a-4525-9e2d-8a9ab428db2f

Office: https://www.globalkeysolutions.net/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe