USFDA issues Form 483 with 8 observations to Aurobindo's Telangana unit
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USFDA issues Form 483 with 8 observations to Aurobindo's Telangana unit
Synopsis
Aurobindo Pharma faces scrutiny. The US FDA inspected its Bachupally, Telangana plant. The inspection occurred between August 25 and September 5. Following the inspection, the US FDA issued a Form 483. The form contained eight observations. Aurobindo Pharma stated the observations are procedural. The company plans to respond to the US FDA within the given timeframe.
By PTI
Aurobindo Pharma on Friday said the US health regulator has issued a Form 483 with eight observations after inspecting its Telangana-based manufacturing plant.
At the end of the current inspection, a 'Form 483' was issued with a total of eight observations for both (oral solids & injectable, it added.
"All observations are procedural in nature. We will respond to the US FDA within the stipulated timelines," the company said.
As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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The US Food and Drug Administration (US FDA) inspected the company's Unit-XII, which includes both oral solids and injectable manufacturing units, situated at Bachupally, Telangana from August 25 to September 5, the Hyderabad-based drug firm said in a regulatory filing.At the end of the current inspection, a 'Form 483' was issued with a total of eight observations for both (oral solids & injectable, it added.
"All observations are procedural in nature. We will respond to the US FDA within the stipulated timelines," the company said.
As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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