Biocon gets 6 USFDA observations for Bengaluru plant

The United States Food and Drug Administration (USFDA) concluded a pre-approval inspection of Biocon's insulin drug substance manufacturing facility triggered by a New Drug Application submitted by the company's insulin API customer, a company spokesperson said in a statement.

Bengaluru: Biotechnology major Biocon Wednesday said the US health regulator has issued six observations in Form 483 after pre-approval inspection of its insulin drug substance manufacturing facility in Bengaluru.

The United States Food and Drug Administration (USFDA) concluded a pre-approval inspection of Biocon's insulin drug substance manufacturing facility triggered by a New Drug Application submitted by the company's insulin API customer, a company spokesperson said in a statement.

"The inspection at the Bengaluru facility took place between February 25-March 5, resulting in a Form 483 with six observations," it added.

Medical Dialogues had earlier reported that Biocon had announced that the USFDA concluded two pre-approval inspections of Biocon’s manufacturing facilities in Bengaluru. The pre-approval inspection of the Biocon additional new injectable manufacturing line for a biological product resulted in Form 483 with two observations. The inspection was conducted from 7 February to February 15, 2019.

Also Read: 2 Biocon Bengaluru facilities undergo USFDA pre-approval inspection, One gets two observations

Biocon in its recent statement, said that the company is confident of addressing these expeditiously and remains committed to global standards of quality and compliance.

The FDA Form 483 is issued to a firm's 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."

Biocon was founded in 1978 with US$140 as the initial capital, failing to find any financial institution for investment. The operations began out of the garage of a rented house with two employees.

The company manufactures generic active pharmaceutical ingredients (APIs) that are sold in over 120 countries across the globe, including the developed markets of the United States and Europe.

It also manufactures novel biologics, as well as, biosimilar insulins and antibodies, which are sold in India as branded formulations.

Also Read: Oops- Biocon chief fined Rs 9.5 lakh by Infosys