A month after Biocon was handed a Form 483, documents reveal lackluster conditions
In September, Biocon got out in front of a Form 483 it was handed by the FDA in a rare out-of-the-country inspection, insisting that the hiccup would not hinder its plans for the commercialization of insulin aspart in the US.
Now, after it’s been released to the public, that Form 483 highlights an unqualified distribution system, inadequate aseptic monitoring and leaky drains, among other issues at its Malaysia subsidiary.
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