Aarti Pharmalabs Completes US FDA Inspection with One Observation
Filing Summary
Aarti Pharmalabs Ltd has announced the completion of a United States Food and Drug Administration (US FDA) inspection at its Unit-IV facility in Tarapur, Maharashtra. The inspection concluded on March 27, 2026, resulting in the issuance of a ‘Form 483’ with one procedural observation. The company plans to submit corrective and preventive actions to the US FDA within the required timeframe. This update is in accordance with Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Aarti Pharmalabs Ltd has informed the BSE and NSE about the completion of a US FDA inspection at its Unit-IV facility located in Tarapur, Maharashtra. The inspection was conducted at Plot No. E-50, 50/1, 59/1, MIDC, Tarapur, Tal. & District Palghar, and concluded on March 27, 2026.
At the end of the inspection, the US FDA issued a ‘Form 483’ with one observation. The observation is procedural in nature. Aarti Pharmalabs has stated that it will submit the necessary corrective and preventive actions to the US FDA within the stipulated period as required.
This disclosure is made in compliance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company has requested that this information be taken on record by the relevant authorities.
Aarti Pharmalabs Ltd is engaged in the pharmaceutical sector, focusing on the development and manufacturing of active pharmaceutical ingredients and intermediates. The company prioritizes compliance with international regulatory standards to maintain its position in the global market.