Company: Kaken Pharmaceutical Co Ltd.Date: 7/27/01
Product: Drug Products
Written procedures for production, process control, and laboratory operations were not always followed to assure that APIs have the appropriate quality and purity. The inspection reported numerous instances regarding the following operations which present a general practice of not following written procedures:
-Stability testing
-Storage of quarantined and released materials
-Making software changes
-Drying of finished API
FDA District: Rockville, MD
