Schering-Plough Products, LLC — FDA 483 Findings

You have not developed validation/qualification master plans encompassing process, cleaning, computer and analytical method validation as directed by the Corporate Quality Assurance Guideline titled Master Plans for Validation/ Qualification issued 10/12/1999.

Your performance qualification of the manufacturing process ofPotassium Chloride ER Coat in the "epee RRM: is inadequate, in that, it does not reflected your actual manufacturing process procedure.

The laboratory analytical balances used for the testing of your products do not comply with the USP 24 Chapter <41> Weights and Balances.

The content uniformity testing performed during blend uniformity validation does not ensure a uniform blend of the Extended Release coated Potassium Chloride crystals used to manufacture K-Dur 10 and 20 mEq tablets.

Your Out of Specifications (OOS) laboratory investigations system is inadequate in that: a.

Variance investigation 20000482 conducted during the qualification ofPotassium Chloride manufactured byMEBs not adequate.

Corrective actions you commited to in your response dated October 12, 1999 to the FDA-483 issued on September 21, 1999 concerning data maintance and security in laboratory instruments have not been completed.

After obtaining an Out-of-Specification assay result during the validation the K-Dur extended release coating process, you reanalyzed the same sample preparation.

During the course of the inspection, the following records were not available for review: a.

Analysis performed in order to accept Potassium Chloride active pharmaceutical ingredient are performed on a sample your receive from your supplier and not the actual Potassium Chloride, USP received.

Preliminary variance report 20010219 was initiated to document a low net yield and a interruption during processing ofK-Dur ER coated pellets lot 0210071-D in the Glatt.