Drug firm Dr Reddy's Laboratories today said it has received five observations from the US health regulator for its API plant at Medak in Telangana.
Drug firm Dr Reddy's Laboratories today said it has received five observations from the US health regulator for its API plant at Medak in Telangana.
The audit of the company's API Hyderabad plant 3 at Medak district by the United States food and Drug Administration (USFDA) has been completed today, Dr Reddy's Laboratories said in a filing to BSE. "We have been issued a Form 483 with five observations," it added.
The observations are related to procedures and facilities maintenance, Dr Reddy's said. It however did not give specific details about the observations. "We will address them comprehensively within stipulated time," it added.
As per the USFDA, an FDA Form 483 is issued to a firm's management at the conclusion of an inspection when investigators have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts.
It notifies the company's management of objectionable conditions at the facility.
