USFDA inspection: Alembic Pharma gets Form 483 with 5 observations
Vadodara: Drugmaker, Alembic Pharma, has recently announced that the company has received a Form 483 with 5 procedural observations from US Food and Drug Administration (USFDA) after an inspection of the company's Solid Oral Formulation Facility (F-4) located at Jarod.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"We would like to inform that the United States Food and Drug Administration (USFDA) has conducted PAI (Pre-Approval Inspection) at Alembic Pharmaceuticals' Solid Oral Formulation Facility (F-4) located at Jarod. The USFDA issued a Form 483 with 5 procedural observations," the company stated in a recent BSE filing,
"None of the observations are related to data integrity, and management believes that they are addressable," the company further stated.
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