Schering-Plough runs into problems with FDA again over manufacturing plants

Schering-Plough has once again fallen foul of the US Food and DrugAdministration after the agency completed inspections of the company's manufacturing facilities in Kenilworth and Union, New Jersey, USA, and in Las Piedras and Manati, Puerto Rico. Originally, the FDA found deficiencies concerning compliance with current Good Manufacturing Practices during recent inspections of the plants, primarily related to production processes, controls and procedures (Marketletter February 26).

The agency has issued new inspection reports, called Form FDA-483 and based on visits in May and June, which cite "some continuing and some additional deficiencies concerning compliance" with cGMPs. S-P says that it is in the process of responding to the reports and is continuing to discuss these problems with the agency, but claims that "it has moved aggressively and deliberately in an effort to resolve these manufacturing issues."

Firm says more work needs to be done