MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT
- In a regulatory update submitted to the Indian Stock Exchanges, Mumbai headquartered Indoco Remedies Ltd said of its Goan plants inspected and having received Establishment Inspection Report (EIR).
In a press-release submitted to the Indian Bourses, titled - "Indoco receives EIR for its manufacturing facilities in Goa (Plant II & III) Mumbai," it further read that, Indoco Remedies Limited announced today, the receipt of Establishment Inspection Report (EIR), from the US Food and Drug Administration (USFDA) for its sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa for the inspection carried out between 7th October to 15th October, 2019.
This was a Pre-Approval Inspection for a sterile injectable product, with 2 observations on Form 483s, which is now concluded as closed, the company statement claimed.
The inspection classification of this site has been determined as VAI (Voluntary Action Indicated) by the USFDA.
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