Alembic Pharmaceuticals announced that the United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals New Injectable Facility (F-3) located at Karkhadi from January 29, 2021 to February 06, 2021. This was a scheduled inspection and at the end of the inspection, the USFDA issued a Form 483 with 5 observations.
None of the observations are related to data integrity and are procedural in nature.
The Company is preparing the response to the observations, which will be submitted to USFDA shortly.
The Company is committed to maintain highest quality standards that meet USFDA standards.
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