Schering-Plough Products, LLC — FDA 483 Findings

On this same page it discusses the out of guideline results for lots 1-AHU-3 and 1- AHU-4.

There is insufficient evidence to assure that the current processes used for manufacture of the products listed below will consistently produce a product meeting its predetermined specifications.

Raw Materials a) You have not executed the new Audit Qualification Plan 2001 to audit suppliers of active ingredients and raw materials as committed in your response to the previous FDA-483.

Corrective actions when atypical results are obtained during stability testing sometimes involve the removal of the failing samples from the stability program.

You fail to demonstrate the effectiveness ofyour media to promote the slow-growth microorganisms that may be found in your environment.

Your laboratory investigations are inadequate in that atypical and unexpected analytical results are invalidated without adequate investigations which include examination of possible causes for the problem, determination of the root cause of the problem, possible involvement of other lots of the product or other products, and appropriate corrective actions to prevent recurrence of the problem.

You changed your manufacturing process for sterile products by including a re-filtration process of different products when the filters used in the aseptic filtration failed to meet the filter integrity test.

There is no assurance that the training provided during year 2000 and 2001 to your analysts is adequate as evidenced in the following laboratory events: a) During Laboratory Investigation # 99-BU-079 initiated on 9/13/99 to investigate an OOS result in the assay of Beclomethasone Dipropionate, you concluded that the OOS result was caused by a pipetting error by the analyst.

You fail to have adequate microbiological controls in your sterile process operations as evidenced by the following: a) You lack adequate validation of your cleaning and sanitation process for the different filling areas to assure compliance, adequate microbiological controls and a minimum risk of contamination of the products processed aseptically in sterile filling rooms 48, 49, 52, 55, $6 and 68.