Aarti Pharmalabs Gets 1 Observation in USFDA Inspection at Tarapur Unit
Mumbai: Aarti Pharmalabs Limited has successfully completed an inspection by the United States Food and Drug Administration (USFDA) at its Unit-IV facility located in Tarapur, Maharashtra.
The inspection concluded on March 27, 2026.
According to an official communication submitted to stock exchanges, the US FDA conducted the inspection at the company’s manufacturing site situated at MIDC, Tarapur, Palghar district. At the conclusion of the inspection, the regulatory authority issued a Form 483 with one observation.
The company clarified that the observation is procedural in nature and does not indicate any significant compliance issues. Aarti Pharmalabs further stated that it will submit the required corrective and preventive actions (CAPA) along with compliance details to the US FDA within the stipulated timeline.
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