US FDA details problems that led to Biocon’s Form 483

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Roman Valiev)
(Image: Getty/Roman Valiev)

Related tags: Biocon, Form 483, API quality, India

The published Form 483 details five points of concern raised by inspectors to the company’s API facility in India.

Biocon revealed that it had been issued a Form 483 by the US Food and Drug Administration (FDA) last month​, after a pre-approval and good manufacturing practice (GMP) inspection.

At the time, the company said that it had responded with a Corrective and Preventative Action Plan and was “confident of addressing these observations expeditiously​.”

The inspection took place at Biocon’s active pharmaceutical ingredient (API) plant in Bangalore, and the FDA discovered five points of concern.

After publishing the inspection report on its website, the details are now revealed and show that the plant experienced a range of issues, from quality control to labelling.

In particular, the FDA’s report noted that there were issues with cleaning validation protocols to assess potential product-to-product carryover not being performed adequately.

In addition, the review, verification and control of documents related to the production, testing, analysis, review, release and rejection of intermediate and finished API products was found to be deficient.

The inspectors noted, No records are generated or verified with respect to approval/quarantine/reject labels applied to in-n-process, intermediate, or finished API product.

“Labels are generated using word processing software; labels are not verified for accuracy in regard to batch number, inspection lot number, or retest date, prior to being affixed to product containers. Additionally, no reconciliation of generated labels is performed.”

After the release of the details, the share price of Biocon fell by 8% to date – though this will have been influenced by the general fall of stock across the Indian stock exchange that coincided with the first officially confirmed death of a patient due to the coronavirus​.

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