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Alembic Pharma Gujarat facility gets 5 USFDA observations
New Delhi: Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its facility at Karkhadi, Gujarat.
"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-February 5, 2021.
This was a scheduled inspection and at the end of the inspection, the USFDA issued a form 483 with 5 observations, the company said in a regulatory filing.
As per the USFDA, a Form 483 is issued to a firm''s management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company''s management of objectionable conditions.
Read also: Alembic Pharma Net Profit Rises 25 Percent To Rs 293 Crore In Q3
Alembic Pharma said none of the observations were related to data integrity and were procedural in nature.
"The company is preparing the response to the observations, which will be submitted to USFDA shortly," the company said.
Read also: Alembic Pharma Secures USFDA Nod For Midodrine Hydrochloride Tablets
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751