Alembic Pharmaceuticals said it has been issued with a Form 483 by the US Food and Drug Administration after the drug regulator conducted a routine inspection of its formulations facility in Panelav in Gujarat.
Form 483 is issued to firm management at the conclusion of an inspection when an investigators observes conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related laws. The form notifies the company’s management of objectionable conditions.
“None of the observations are related to data integrity or repetitive in nature,” Alembic Pharmaceuticals said, adding that a total of three observations were made.
“The company is preparing the response to the observations, which will be submitted to the US FDA shortly,” it added.
The issuing of 483 does not constitute a final decision on violations. The company will be given a chance to respond.
The form, along with a written report called an Establishment Inspection Report, other evidence collected on-site and the company’s response will be considered while making a final decision.
Alembic Pharmaceuticals Ltd. is involved in manufacture of pharmaceutical products, pharmaceutical substances and intermediates.
The company’s Panelav plant houses active pharmaceutical ingredients (APIs) and formulation manufacturing, while its Sikkim plant is involved in manufacture of formulations for Indian and non-regulated export markets.