Day

April 6, 2015
Recipient: Yunnan Hande Bio-Tech. Co. Ltd..Product: active pharmaceutical ingredients . Date: 4/6/2015 Our investigators observed specific deviations during the inspection, including, but not limited to, the following: 1. Failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. You lacked controls to prevent the unauthorized manipulation...
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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

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