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2 Biocon Bengaluru facilities undergo USFDA pre approval inspection, One gets two observations


2 Biocon Bengaluru facilities undergo USFDA pre approval inspection, One gets two observations

However, 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.

Bengaluru: Biotechnology major Biocon has announced that the United States Food and Drug Administration (USFDA) concluded two pre-approval inspections of Biocon’s manufacturing facilities in Bengaluru.

The inspection of the facility was conducted from February 11 to February 15, 2019. There was no observation and no Form 483 was issued after the pre-approval inspection of Biocon’s Oral Solid Dosage Facility conducted.

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. The FDA Form 483 notifies the company’s management of objectionable conditions.

“There were no observations and no Form 483 was issued after the pre-approval inspection of our Oral Solid Dosage facility conducted between February 11-15,” the company said in a release.

Also Read: USFDA completes inspection of Biocon Bengaluru plant with no observations

However, the pre-approval inspection of the company’s 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.

Commenting on the same, the company said, “Biocon intends to address these expeditiously.”

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: USFDA completes Biocon Telangana plant inspection, no observations issued

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