Glenmark Pharmaceuticals has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (U.S. FDA) for its formulations manufacturing facility in Goa, with the inspection classified as Voluntary Action Indicated (VAI). The FDA inspection was conducted from June 22 to June 30, 2026, the company said in an exchange filing.
The development follows Glenmark’s June 30 disclosure that the FDA had issued a Form FDA 483 containing six observations at the close of the inspection. According to the company, none of the observations related to data integrity, all were procedural in nature and none were repeat observations.
Glenmark had also said at the time that it did not anticipate any impact on the supply of its commercial products and would respond to the FDA within the stipulated timeline.
Under the FDA’s inspection framework, the regulator defines VAI as a classification where objectionable conditions or practices were identified, but the agency is not prepared to take or recommend administrative or regulatory action.
The other two inspection classifications are No Action Indicated (NAI), where no objectionable conditions or practices are found, and Official Action Indicated (OAI), where regulatory or administrative action is recommended.
The FDA says its final classification is determined after considering information gathered during the inspection, the establishment’s response to the Form 483 and proposed or completed corrective actions, among other information. A Form 483 itself is not a final agency determination that a condition violates the law.
