New Delhi : Drug major Dr Reddy’s Laboratories said the US health regulator has issued 11 observations after inspecting its manufacturing plant in Hyderabad.
“The audit of our formulations manufacturing plant-3 at Bachupally, Hyderabad by the USFDA has been completed today. We have been issued a Form 483 with 11 observations,” Dr Reddy’s Laboratories said in a regulatory filing.
The observations by the US Food and Drug Administration (USFDA) are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems, it added.
“We will address them comprehensively within the stipulated time,” the drug firm said.
Earlier this month, the USFDA issued two observations after inspecting company’s manufacturing plant at Srikakulam in Andhra Pradesh.
As per the USFDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.
The FDA Form 483 notifies the company’s management of objectionable conditions.
Dr Reddy’s shares today ended 0.23 per cent up at Rs 2,599.15 a piece on the BSE.