BIOCRAFT UNDER FDA INSPECTION

New Jersey, USA-based generic drugmaker Biocraft Laboratories is the most recent to have its manufacturing facilities come under the scrutiny of the Food and Drug Administration with regard to manufacturing practice compliance issues.

Biocraft has confirmed that it has received notification of an inspection report from the FDA alleging deficiencies, after the Agency's officials had made a series of inspections. However, the Wall Street Journal points out that this could not have come at a worse time, since Biocraft has publicly announced that it is looking to "enhance" its value by means including a merger or a sale.

Hemant Shah of HKS & Co has seen the lengthy inspection report, and feels that there are no "extremely serious problems." But he adds that it does mean no new drug approvals or a sale for the company until matters are resolved. Biocraft has more than a dozen drugs awaiting FDA approval.