US drug regulator cracks down on Hetero, Visakhapatnam warehouse under scanner

The US drug regulator has turned its lens on Hetero, issuing back-to-back Form 483s to its API Unit 9 and warehouse in Visakhapatnam after inspections conducted between September 19th and 26th, 2025.

CNBC-TV18 has accessed the Form 483 issued to the warehouse, which lists six observations — the very first of which, according to regulatory experts, could invite legal action. It states that access to the warehouse storing APIs intended for the US market was not made readily available for inspection and that the facility itself had not been disclosed to the US FDA.

Inspectors were not allowed to inspect a truck full of drums stationed at the warehouse, which left the warehouse without any explanation provided. Another incoming truck was turned away by security upon their indication of the USFDA personnel at their facility.

In a more troubling admission, the Form 483 states that the Assistant Warehouse Manager and Assistant VP told investigators that the site was meant only for domestic storage and that they were unaware of how or why drums from USFDA-registered facilities were stored there — a statement that effectively points to falsification and lack of oversight by site leadership, according to regulators.

The remaining observations flag weak warehousing controls, poor documentation, and absence of quality unit oversight — all indicators of systemic lapses in Good Manufacturing Practices, say experts.

The earlier Form 483 issued to Hetero’s API Unit 9 also carried six observations across 14 pages, highlighting deficiencies in cleaning validation, inadequate documentation practices, and poor equipment maintenance, signalling wide quality and compliance gaps. Analysts say this could benefit Aurobindo Pharma and Laurus Labs, both of which have ARV portfolios that could overlap with Hetero’s.

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