Alkem Labs' Daman Facility Gets 7 USFDA Observations, Classified as OAI
Mumbai: Alkem Laboratories Ltd has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has classified its manufacturing facility at Amaliya, Daman, as Official Action Indicated (OAI) following an inspection conducted earlier this year.
The company stated that the announcement follows its earlier intimation dated May 2, 2026, regarding the USFDA inspection carried out at the Amaliya, Daman manufacturing facility from April 20, 2026, to May 1, 2026. At the conclusion of that inspection, the USFDA had issued a Form FDA 483 containing seven observations.
In its latest communication, Alkem Laboratories said that the USFDA has now classified the inspection status of the facility as Official Action Indicated (OAI). An OAI classification indicates that the regulator has identified objectionable conditions during the inspection and that regulatory or administrative actions may be considered.
The company, however, clarified that the Amaliya manufacturing facility continues to manufacture and supply approved products to the United States market despite the inspection classification.
According to Alkem Laboratories, it will continue to work closely with the USFDA to achieve a fully compliant status. The company reiterated its commitment to addressing the regulator's concerns and complying with applicable regulatory requirements.
Also Read: Alkem Gets EU GMP Compliance Certificate for Daman Facility from Malta Authority
