Ansell International

7. You have failed to establish appropriate procedures to assure that computerized processing control systems and data storage systems used in the production and quality systems at Ansell, Inc. are secured and managed to assure the integrity of processes and data that could effect the conformance of the condoms to established specifications. Examples of such failure include the following:
a. You have failed to establish management approval procedures for software installed on PLC’s which control major process functions throughout the plant including compounding, condom dipping, and electronic testing.
b. You have failed to assure the retention and security of captured processing data from the compounding PLC in that no backup power supply was provided for the desktop computer used to capture, store and process the data.
d. The master programs for each PLC are not clearly named or otherwise related to the pertinent PLC’s, either as stored on the engineering computer hard drive or by any other listing, to assure they can be properly retrieved to evaluate system problems or to prepare updates. Ansell, Inc. had no established procedure to control the secure retention of these master programs, or to identify and retain all versions as updates are written.
8. You have failed to establish procedures to assure that computerized documents which form part of the device master record and/or the quality system record are prepared and approved as required by document control provisions of the Quality System Regulation at 21 CFR 820.40. Examples of such failure are as follows
a. Primary engineering drawings for manufacturing equipment used in condom production, and for the devices themselves are stored in AutoCAD form in a desktop computer. These drawings are not stored in approved hard copy, or otherwise approved form. The storage device was not protected either mechanically or by password control from unauthorized access and modification of the drawings.

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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