Alkem Laboratories announced that its manufacturing facility in Amaliya, Daman, has been classified as Official Action Indicated (OAI) by the US FDA. This follows an inspection conducted from April 20 to May 1, 2026, which resulted in a Form FDA 483 with seven observations. Despite this classification, the company continues to manufacture and supply products from this facility to the U.S. market and is working with the regulator to achieve full compliance.
US FDA Inspection Update for Amaliya Facility
Alkem Laboratories Limited has provided an update regarding the US FDA inspection at its manufacturing facility located in Amaliya, Daman. This announcement follows a previous intimation dated May 2, 2026. The inspection, which took place from April 20, 2026, to May 1, 2026, resulted in the issuance of a Form FDA 483 containing seven observations.
Facility Status Reclassified
The company has now been informed that the US FDA has classified the inspection status of the Amaliya facility as Official Action Indicated (OAI). Alkem Laboratories affirms that it continues to manufacture and supply approved products from this facility to the U.S. market.
Commitment to Compliance
Alkem Laboratories stated its commitment to working with the regulator to achieve fully compliant status for the facility. The company has requested that this update be taken on record.
Source: BSE
