Cadila says Moraiya drug plant has passed US FDA inspection

By Gareth Macdonald contact

- Last updated on GMT

Cadila facility in Moraiya (source Cadila)
Cadila facility in Moraiya (source Cadila)
Cadila Healthcare says its formulation plant in Moraiya, Gujarat has passed a US Food and Drug Administration (FDA) inspection with no Form483 observations.

The firm announced the results of the inspection in a Bombay Stock Exchange (BSE) filing​ today, explaining that US agency inspectors visited the drug formulation facility from August 31 to September 7.

The successful inspection comes nearly two years after Cadila – part of the Zydus Group – was issued with a warning letter​ by the US FDA. According to a Cadila filing​ the plant passed a follow-up inspection conducted in February.

This suggests the latest audit was prompted by Cadila desire to produce a new product at the site for the US market.

The firm did not respond to a request for comment.

The Moraiya facility is one of four finished formulation plants operated by the Zydus Cadila group in India.

It is not the same site that was issued with a Notice of Concern (NoC) by the World Health Organisation (WHO) in October 2015​.

According to the WHO the NoC prompted Cadila to suspend production of its rabies vaccine Lyssavac-N and recall all batches of the vaccine made at the site since April 2015.

Related topics: Regulatory & Safety, Regulations, QA/QC

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