Sun announced the Form 483 in a Bombay Stock Exchange (BSE) filing on Saturday, explaining that the Food and Drug Administration (FDA) inspection team which audited the site on April 13 identified 11 issues. Details of the problems were not provided.
The Indian drug manufacturer said it is responding to the letter but declined to comment when contacted by in-Pharmatechnologist.com.
The plant which opened in 2002 manufactures active pharmaceutical ingredients (APIs) and oral sold drugs – tablets and capsules – for India and international markets. According to Sun’s website the facility has capacity to produce 2400mill tablets a year.
US FDA
The Form 483 comes months after the US FDA told Sun it had more to do to bring its plant in Halol, Gujarat – which also makes finished drug products – up to code.
Sun has been working to address problems at the Halol facility since 2015 when it was issued with a warning letter by the US FDA.
Sun had expected Halol regain compliance last year.
However, in December it announced it had received a new Form 483 after an inspection earlier that month. In February, the firm said it had submitted its response to the US regulator.
According to Sun, the Halol problems impacted its US revenues in fiscal 2016.