Yunnan Hande Bio-Tech. Co. Ltd.

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 of your laboratory’s electronic raw data. Specifically, your infrared (IR) spectrometer did not have access controls to prevent deletion or alteration of raw data. Furthermore, the computer software for this equipment lacked active audit trail functions to record changes to data, including information on original results, the identity of the person making the change, and the date of the change. Audit trails that capture such critical data about the quality of your batch production should be reviewed as part of the batch review and release process.

We acknowledge your commitment to upgrade the IR software by adding full audit trail capabilities in compliance with CGMP. In your response, you also commit to obtain information about the (b)(4) archival of all data obtained on laboratory computerized systems, and to evaluate software upgrades to other instrumentation. However, your response is inadequate because you have not specified how you will ensure the integrity of raw analytical data or maintain data before you complete your planned corrective actions and preventive (CAPA) actions.

In response to this letter, provide your comprehensive CAPA plan for ensuring that electronic data generated in your manufacturing operations, including laboratory testing, cannot be deleted or altered. It essential that your firm implement controls that prevent the omission of data, and record information about changes to existing data, such as the date of the change, identity of person who made the change, and an explanation or reason for the change. Any such changes should be made in accordance with an established and appropriate procedure. Your response should address your laboratory equipment and any other manufacturing-related equipment that may be affected by the lack of adequate controls to prevent data manipulation

FDA District Office: CDRH

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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.