Aarti Pharmalabs Limited 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 27th March 2026, resulting in the issuance of a ‘Form 483’ with a single observation.
The observation noted by the US FDA is procedural in nature, according to the company’s statement. Aarti Pharmalabs has committed to submitting corrective and preventive actions along with compliance documentation to the US FDA within the stipulated timeframe.
The inspection was conducted at the company’s facility located at Plot No. E-50, 50/1, 59/1, MIDC, Tarapur, Tal. & District Palghar, Maharashtra – 401506.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).