Alkem Labs' Daman Facility FDA Inspection Classified OAI
Alkem Laboratories' Daman manufacturing facility's US FDA inspection has been classified as Official Action Indicated (OAI). The company received seven observations during the April 20-May 1, 2026 inspection. Alkem continues to supply products from the facility to the US market and is working towards full compliance.
An OAI classification can lead to restrictions on product approvals or shipments, potentially impacting future revenue from the U.S. market, though the company states it continues to supply products.
The US FDA has classified the inspection status of Alkem's Daman facility as Official Action Indicated (OAI), which is a negative regulatory development.
Alkem Laboratories Limited has provided an update regarding the US FDA inspection conducted at its manufacturing facility in Amaliya, Daman. This inspection took place from April 20, 2026, to May 1, 2026. During the inspection, the company received a Form FDA 483 with seven observations.
Following this, the US FDA has now classified the inspection status of the Daman facility as Official Action Indicated (OAI). Despite this classification, Alkem Laboratories continues to manufacture and supply approved products from this facility to the U.S. market. The company stated its commitment to working with the regulator to achieve fully compliant status.
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