27
Jul
2001

Kaken Pharmaceutical Co Ltd.

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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IEC 29119-1 Software and System Testing

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