USFDA flags Hetero Labs’ Nakkapalli facility with six serious observations

US regulators have raised serious compliance concerns at Hetero Labs’ Nakkapalli facility in Andhra Pradesh by issuing a Form 483 with six important observations.

The inspection, conducted by the US Food and Drug Administration between September 19 and 26, found lapses in quality control procedures and the use of an unregistered testing laboratory outside of official facilities.

The USFDA also noted that finished active pharmaceutical ingredients intended for the U.S. market were being released into an off-site warehouse without proper documentation. Other procedural deficiencies were cited, including the failure to record out-of-specification results from the unregistered laboratory, raising questions about the company’s compliance with regulatory standards.
Hetero Labs is a major player in the active pharmaceutical ingredient market and the second largest in the antiretroviral segment. Experts suggest that any escalation in regulatory measures could disrupt supplies to the Nakkapalli plant, potentially benefiting competitors such as Laurus Labs and Aurobindo Pharma.

The market is now closely monitoring Hetero Labs’ Form 483 response and subsequent USFDA actions, which will determine the long-term impact on the company’s operations and supply chain.