Gland Pharma543245Audit report shared

USFDA unannounced inspection at Dundigal formulation facility concludes with four Form 483 observations

USFDA conducted an unannounced cGMP inspection at the company's formulation facility at Dundigal.

By ScoutQuest · Fri 23 Oct 2026, 4:22 PM IST · 2 min read

Inspection Period: October 12, 2026 to October 23, 2026
Form 483 Observations: four (4) Form 483 observations
Stated Impact: Not Applicable

What happened

USFDA conducted an unannounced inspection on Current Good Manufacturing Practice (cGMP) at the company's formulation facility at Dundigal. The inspection ran from October 12, 2026 to October 23, 2026 and concluded with four (4) Form 483 observations.

What the company says about the observations

The four (4) observations are procedural in nature.
They are not repeated observations.
They are not related to data integrity.
Corrective and preventive actions for these observations will be submitted to the USFDA within the stipulated period.

How the company described the outcome

In the Annexure to the exchange intimation, the authority is named as the United States Food and Drug Administration and the action is described as a Form 483 with four (4) observations, received on October 23, 2026. Against the column on details of violations or contraventions, the company has marked "Not Applicable".

Impact stated by the company

Against the column on impact on financial, operational or other activities of the listed entity, quantifiable in monetary terms to the extent possible, the company has marked "Not Applicable". No monetary figure is attached to the inspection outcome in the intimation.

What investors may watch

Submission of the corrective and preventive actions to the USFDA within the stipulated period.
Any subsequent communication from the USFDA after that submission.
Whether any further disclosure is made on the Dundigal facility.

How this can be read

A Form 483 with four (4) observations at a US-facing formulation site can draw attention, since US supplies matter to such businesses. At the same time, the company's own characterisation of the observations as procedural, non-repeated and unrelated to data integrity, and its "Not Applicable" entry on financial impact, present the outcome as one being handled through a corrective action response rather than as a stated financial or operational setback.

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