The US Food and Drug Administration (USFDA) has issued the alert under 'Import Alert 66-40', which authorises the health regulator "detention without physical examination of drugs from firms which have not met drug GMPs".
The company's plant in Pune district manufactures active pharmaceutical ingredients and speciality chemicals. The products are exported to over 30 countries including the US, UK, Germany and France.
The drug firm's Pune-based plant is approved by Maharashtra FDA. The facility is spread across an area of over 12,000 square feet.