FDA EIR - Deccan Nutraceuticals Private Ltd. - April 20, 2023

A recent FDA inspection of Deccan Nutraceuticals Private Limited, an intermediate and drug substance manufacturer located in Markal, Pune, India, concluded without any observations. Conducted from April 17-20, 2023, this pre-announced inspection adhered to Current Good Manufacturing Practices (cGMP), specifically compliance program CP7356.002F for Active Pharmaceutical Ingredient (API) Process Inspection, and incorporated ICH Q7 Guidance. The inspection thoroughly assessed the company's Quality, Materials, Production, and Laboratory Control systems.

Crucially, the current inspection confirmed the effectiveness of corrective actions previously implemented by Deccan Nutraceuticals. A prior FDA inspection from August 6-10, 2018, had cited two observations: an uninvestigated deviation of raw material from supplier certificates during vendor qualification, and unvalidated clean hold time for manufacturing equipment. The company provided written responses with corrections on August 31, 2018, which were found to be adequate and resolved during the recent visit.

Given that no new issues or violations were identified, the current inspection received a "No Action Indicated (NAI)" classification, signifying that no further regulatory steps are required from the FDA. Deccan Nutraceuticals Private Limited continues to supply intermediates and APIs to global markets, including the United States.