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Dr. Reddy’s Srikakulam Plant Draws USFDA Scrutiny with 7 Observations

Updated: July 18, 2025 18:28

Image Source : Medical Dialogues
Dr. Reddy’s Laboratories Ltd has received a Form 483 from the US Food and Drug Administration (USFDA) following a detailed inspection of its formulations manufacturing facility (FTO 11) in Srikakulam, Andhra Pradesh.
 
Key inspection details:
 
- The inspection was conducted from July 10 to July 18, 2025, covering both Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI) protocols.

- The USFDA issued seven observations, highlighting procedural and documentation gaps that require corrective action.
 
Company response:

- Dr. Reddy’s has confirmed its intent to address all observations within the stipulated timeline.

- The company emphasized its commitment to maintaining global compliance standards and ensuring uninterrupted product supply.
 
Operational context:

- The Srikakulam facility plays a key role in Dr. Reddy’s global formulations pipeline.

- The inspection outcome may influence future product approvals and regulatory timelines.
 
Sources: Moneycontrol, The Hindu Business Line, Economic Times Markets, USFDA Inspection Filings

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