Aarti Drugs Limited has submitted a regulatory disclosure under Regulation 30 of the SEBI LODR Regulations, 2015.
The disclosure concerns an inspection conducted by the United States Food and Drug Administration (US FDA) at the formulations manufacturing facility of the company's wholly-owned subsidiary, Pinnacle Life Science Private Limited. The facility is located in Baddi, Himachal Pradesh.
The inspection was conducted from November 2, 2026, to November 6, 2026.
Upon conclusion of the inspection, the subsidiary received a Form 483 from the US FDA on November 6, 2026. The form contained 3 inspectional observations.
A key detail provided is that none of the 3 observations are related to Data Integrity.
The company states that it will work closely with the US FDA to resolve all the points raised in the observations.
The disclosure explicitly states that there is no impact on the financial, operational, or other activities of Pinnacle Life Science Private Limited as a result of receiving this communication.
The disclosure includes an Annexure A, which is a completed 'Form A' as required by Regulation 30(13) of the SEBI LODR Regulations. This form systematically details the event, confirming the subsidiary's name, the type of communication (Form 483), the date of receipt, the authority (US FDA), a summary of the contents, and the company's response. It also confirms no expected financial implications, no identified aberrations/non-compliances beyond the 3 observations, no penalties or sanctions imposed, and the planned action of working with the US FDA.
The letter is signed by Rushikesh Vivek Deole, Company Secretary & Compliance Officer of Aarti Drugs Limited.