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.
"The Company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times," the company added.
Read also: Alembic Pharma gets USFDA EIR for Oncology Injectable Formulation Facility at Panelav
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. It is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
Products under International Generics are manufactured across its facilities in Panelav, Karkhadi, and Jarod in Gujarat. Under this vertical, the company also has R&D facilities in Vadodara (Gujarat), Hyderabad (Telangana), and New Jersey (USA).
Read also: Alembic Pharma bags USFDA nod for Hypertension drug Nifedipine Extended Release
