FDA Completes Inspection of Marsam Pharmaceuticals

The Food and Drug Administration (FDA) has concluded its inspection of Marsam Pharmaceuticals Inc. (Cherry Hill, NJ), a subsidiary of Schein Pharmaceutical Inc. (Florham Park, NJ). At the close of inspection, Marsam received a Form 483 detailing the FDA's inspectional observations and noting a number of significant deficiencies in good manufacturing practices. Marsam is currently reviewing these observations and accelerating its efforts to address the noted deficiencies.

Marsam had itself initiated actions to address a number of the FDA's inspectional observations by voluntarily recalling all Marsam products within expiry, suspending manufacturing and testing activities, and submitting to the FDA a list of principal points to be included in a corrective action plan. The company intends to work with its outside experts to modify its corrective action plan to ensure it addresses the observations noted in the Form 483 before presenting the plan to the FDA for approval. The proposed plan will include schedules for resumption of manufacture at the site on a product-by-product basis. Additional enforcement actions may be forthcoming.

Schein Pharmaceutical develops and markets a broad line of generic pharmaceuticals and a few branded drugs.

For more information: Martin Sperber, CEO, Schein Pharmaceutical Inc., 100 Campus Dr., Florham Park, NJ 07932. Tel: 973-593-5500. Fax: 973-593-5840.