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New Jersey-based Schering-Plough is phasing out manufacturing operations at its Manati, Puerto Rico, site by the end of 2006, the company announced. In addition, the company will lay off 1,000 workers at its facilities in Puerto Rico and New Jersey.
The FDA's decision to withdraw seven guidances as inconsistent with its pharmaceutical current good manufacturing practices (cGMP) initiative is a sign that the agency is serious about updating its approach to cGMP and taking a more global view of regulations, industry sources say.
The FDA issued a warning letter April 28 to Croatian drug firm Pliva for a variety of manufacturing violations at its Zagreb, Croatia plant. The letter was posted on the FDA's website May 5.
Andrx did not properly investigate product discrepancies and out-of-specification results, according to observations listed on the Form 483 the FDA issued to the company after the agency’s reinspection of the drugmaker’s plant in March.
The FDA issued a warning letter April 28 to Croatian drug firm Pliva for a variety of manufacturing violations at its Zagreb, Croatia plant. The letter was posted on the FDA’s website May 5.
The FDA is withdrawing its direct final rule exempting most investigational drugs from complying with current Good Manufacturing Practices (cGMP) amid criticism of the proposal from a variety of stakeholders.