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Shionogi Facility Cited for Batch Records, Cleaning

December 3, 2019

The FDA hit Japanese API and sterile drug manufacturer Shionogi with a Form 483 for deficiencies in its production batch records and cleaning procedures.

An inspection of the facility in Iwate revealed that the production batch records did not list all facility building locations and room numbers, as well as the make, model and identification numbers of all equipment.

Specifically, process simulation test records for five lots of drug product did not identify the makes, models and identification numbers for machines responsible for filling and stoppering vials and a vial cap machine. Room locations and building location were not always identified on the simulation tests for the five lots, the investigators found.

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