Field notes from the front line of quality.
Practical guidance from Globiox SMEs — FDA readiness, auditing, CAPA, validation, and quality systems for regulated life sciences.
FDA’s Data Integrity citation trends of Biological Products
During the 2016-2018 period, the FDA performed routine inspections of the Biologics and Human Cellular and Tissue Products (HCT/P) facilities in the US and…
March 25, 2020FDA & ComplianceLatest Updates on Regulatory
Editor’s note (August 2026): On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation, incorporating ISO…
July 30, 2019FDA & ComplianceFDA plans major overhaul, looks to be more specialized
5 months ago the FDA announced that in response to “unparalleled challenges” posed by advances in science, globalization and product complexity, the agency…
February 12, 2014FDA & ComplianceCGMP now includes supply chain management
Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012 and addresses several areas, including the drug supply…
December 11, 2013AuditingThe FDA’s “dos” and “don’ts” for responding to a 483
DO! • Include photos where possible. • Include documentation to provide evidence that corrective actions have been implemented. • Pay particular attention to…
November 13, 2013FDA & ComplianceCombined use diagnostic instruments and the FDA’s thoughts
The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.” The recommendations display intent to…
May 15, 2013FDA & ComplianceKeeping up with the FDA
Quite a few companies in FDA regulated industries are experiencing “Dynamic Shock.” After handling their operations and quality assurance in the same manner…
December 11, 2012FDA & ComplianceWarning Letters: What they are, How we can help
As discussed in our previous post, “FDA 483: your company contains critical errors,” a company whose operations are not compliant with the regulations set out…
October 9, 2012AuditingFDA 483: Does your business contain critical errors?
In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed…
August 22, 2012Ready to get inspection-ready?
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