FDA Form 483 shows Pfizer repeating same mistakes at troubled fill-finish plant

16th February 2018 Uncategorised 0

Pfizer said several weeks ago that the FDA had updated the status of its troubled Kansas fill-finish plant, paving the way for drug approvals, and sure enough this week Novartis announced an FDA nod for its Copaxone generic being produced there. But a recently released document from the last inspection of the plant shows it continues to struggle, even repeating issues the FDA pointed out in a previous visit.

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Source: fierce