Pointe Scientific Inc.

Recipient: Pointe Scientific Inc.
Product:Hemoglobin A1c, Liquid Glucose Hexokinase, Liquid Alkaline Phosphatase, Liquid Auto Density Lipoprotein (Auto HDL) Cholesterol and other chemical analyzersr
Date: 8/11/06

Failure to maintain procedures to ensure that the specified design requirements are met; failure to review all complaints to determine whether an investigation is necessary; failure to maintain procedures for implementing corrective and preventive actions; failure to establish complete procedures for investigating the cause of nonconforming products; failure to maintain complete Device Master Records; failure to validate manufacturing processes; failure to establish procedures and monitor production process parameters; failure to validate computer software used to control automated production and quality system operations; failure to conduct quality audits; failure to follow procedures for controlling the storage of products in order to prevent adverse effects; failure to adequately train employees; failure to maintain adequate medical device reporting procedures; and failure of management with executive responsibility to ensure that an effective quality system has been implemented at all levels of the organization.
Letter acknowledges receipt of company’s July 2006 response to FDA 483 but deems it inadequate.

Your firm failed to validate computer software used to control automated production and quality system operations, as required by 21 CFR 820.70(i). For example, your firm has not validated the software used to produce labels and manage your complaints.

FDA District: Baltimore District Office

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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Partners located in the US (CA, FL, MA, MN) and Italy.