Biocon says FDA 483 at Malaysian plant not due to non-compliance

By Dan Stanton

- Last updated on GMT


Related tags Food and drug administration

A US FDA pre-approval inspection of Biocon’s insulin manufacturing facility in Malaysia has resulted in a Form 483 with six observations.

“The US FDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and issued a Form 483 with 6 observations,”​ a Biocon spokesperson wrote in a letter filed with the Bombay Stock Exchange this morning.

“As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner.”

In-Pharmatechnologist reached out to the Bangalore, India-based company for further details:

“These observations are suggested procedural improvements and not related to non-compliance and as such do not have any material impact,”​ we were told.

The facility, located at the Bio-XCell biotechnology park in Johor, Malaysia, makes insulin active pharmaceutical ingredient (API), insulin analogues and finished products.

Biocon began constructing the facility in 2011​ to produce insulin for Pfizer under a 2010 contract, and commercial operations commenced in 2017.

Among the commercial products made at the plant is Biocon’s rh-insulin, Malaysia’s first locally made biosimilar insulin to be approved by the National Pharmaceutical Regulatory Authority (NPRA). The facility also makes the firm’s insulin glargine brand, Basalog – a biosimilar to Sanofi’s Lantus – for a number of markets.

Last April​, an inspection by Ireland’s Health Products Regulatory Authority (HPRA) resulted in the facility receiving a European GMP certificate dated September 6 2017. The certificate can be found below.

The news is the latest regulatory issue to hit Biocon. A facility in Bangalore – which also makes biosimilars – was criticised by European and US regulators last year​.

   GMP Biocon by Dan Stanton on Scribd

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