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# FDA Releases Sekisui Medical FDA-483
- URL: https://www.fdaweb.com/fda-releases-sekisui-medical-fda-483/
- Published: 2017-05-19T12:00:00.000Z
- Updated: 2026-09-14T22:24:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138734

FDA has just released the FDA-483 form listing 10 observations from its 6/13-6/17/16 inspection at Sekisui Medical Co., Iwate, Japan. Deviations from CGMP regulations for active pharmaceutical ingredients noted on the form were:

- failing to maintain and review all raw data;
- failing to prevent unauthorized access of changes to data and to provide adequate controls to prevent omissions of data;
- failing to design and monitor the water system to ensure it is suitable for its intended use;
- failing to ensure cleaning procedures are effective;
- failing to maintain and clean equipment;
- failing to demonstrate process validation is in a state of control;
- failing to establish scientifically sound and appropriate test procedures;
- failing to ensure the active pharmaceutical ingredients meet established specifications for quality and purity;
- failing to establish impurity profiles; and
- failing to establish a system to control the issuance of documents.