USFDA Issues 2 Observations at Dr Reddy's Mexico Facility

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Sep 12, 2026 00:36

USFDA conducted a records assessment at Dr Reddy's API manufacturing facility in Mexico, issuing two observations. Dr Reddy's will respond to the findings.

Key Points

The USFDA conducted a records assessment at Dr Reddy's API manufacturing facility in Mexico.
The assessment resulted in the USFDA issuing two observations to Dr Reddy's.
Dr Reddy's Laboratories will respond to the observations within the stipulated timeline.
The assessment at the Industrias Quimicas Falcon de Mexico facility occurred between July 17 and September 8.

New Delhi, Sep 11 (PTI) Pharmaceutical major Dr Reddy's Laboratories on Friday said the US health regulator has conducted a records assessment of its active pharmaceutical ingredient (API) manufacturing facility in Mexico and issued two observations.

The assessment at the facility -- Industrias Quimicas Falcon de Mexico, SA de CV (Dr Reddy's Laboratories Ltd) -- has been completed by the United States Food and Drug Administration (USFDA), the company said in a regulatory filing.

The assessment was carried out between July 17 and September 8, the filing said, without sharing details of the observations made by the US health regulator.

A records assessment by the USFDA refers to a regulatory review where the agency requests and examines a manufacturing facility's documentation and records to evaluate compliance.

"At the conclusion of the assessment, the USFDA issued a Form FDA 2953 containing two observations, to which we will respond within the stipulated timeline," Dr Reddy's Laboratories said.

Source: PTI By Rediff Money Desk, New Delhi

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