USFDA Issues 7 Observations To Dr. Reddy’s Hyderabad Facility

Pharmaceutical major Dr Reddy's Laboratories on Thursday, May 25, noted that the US Food and Drug Administration (USFDA) has completed a Pre-License Inspection (PLI) at its biologics manufacturing facility in Bachupally, Hyderabad,

This inspection conducted between June 16 to June 25, 2026 resulted in the issuance of the Form-483 with seven observations. The company said it will address within the stipulated timeline.

What is Form 483?

A Form 483 is considered to be a list of observations made during the inspection and is issued by the USFDA inspectors post the conclusion of an inspection. The inspector will address and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination linked to the facility’s GMP compliance.

Previously, the USFDA had conducted a Pre-Approval Inspection (PAI) at the same Hyderabad facility between 4 September and 12 September 2025, after which it had issued five observations.

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The Hyderabad-headquartered Dr. Reddys Laboratories is a global pharmaceutical company, offering a portfolio of products and services such as APIs, generics, branded generics, biosimilars and OTC.

The company posted a 86.14% fall in consolidated net profit to Rs 220.9 crore on 11.51% decline in revenue from operations to Rs 7,546.4 crore in Q4 FY26 over Q4 FY25.

The counter advanced 1.63% to settle at Rs 1,350 on Thursday, 25th June 2026. The NSE and BSE remain closed today on account of Muharram.