Sun Pharma- Notice from USFDA
Sun Pharma on Tuesday said the USFDA has issued a 'Form 483' with ten observations after inspecting its Halol-based manufacturing
As per USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection.
Sun Pharma- Form 483
Sun Pharma- What USFDA Found
investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act.
The USFDA conducted a Good Manufacturing Practices (GMP) inspection of the Halol facility from April 26 to May 9, 2022.
Sun Pharma- USFDA GMP Inspection
Sun Pharma- Company reponse to USFDA
The company is preparing the response to the observations, which will be submitted to USFDA within 15 business days.
For India-based Sun Pharma, it follows a few other manufacturing mishaps in the last year that was one of the greatest news.
Sun Pharma- Other Mishaps
Sun Pharma- Recalls Generic TadalaFil
Sun recalled more than 100,000 bottles of its generic tadalafil tablet for erectile dysfunction distributed in the U.S.
"Incorrect grade" of an inactive ingredient was found to have been added during production.
Sun Pharma- Incorrect Grade of Ingredients
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