The US Food and Drug Administration (FDA) shared details of the Form 483 last week, explaining that inspectors who visited the Bangalore site – called Plot 2- 4 Phase IV - in May and June found 10 deviations from current good manufacturing practice (cGMP).
The regulator raised concerns about Biocon’s failure to properly investigate “visible particulates” in injectable drugs made at the site. It also said the firm had not validated that product sterilization procedures used at the facility are effective.
Among other criticisms the FDA raised concerns about the Bangalore plant’s aseptic areas, describing the system for monitoring environmental conditions as “deficient.”
Biocon referenced the Form 483 in a Bombay Stock Exchange (BSE) filing on July 31. The firm said the “visit was a part of the regular periodic audit for a small molecule injectable.”
“The company has responded to the regulator with a corrective and preventative action plan (CAPA) and is on track to implement them in a timely manner.”
2nd Form 483
The site makes a number of products including atorvastatin, the active ingredient in cholesterol-lowering statins. The site also manufactures large molecule products including insulin glargine.
The Form 483 is not the first it has received this year.
In May the US FDA cited concerns about quality testing among eight observations detailed in a Form 48 issued after an inspection conducted between March 27 and April 7.
ANSM criticism
Publication of the latest Form 483 comes just a few weeks after French regulators found 35 cGMP deficiencies at the site, 11 of which were deemed to be “major.”
The Agence Nationale de Sécurité du Médicament (ANSM) inspection was conducted as part of the EMA’s assessment of the marketing authorisation application (MAA) for biosimilars submitted by Biocon’s biosimilar development and commercialisation partner Mylan.