FDA Investigation: Are You Prepared?
The past year has seen a dramatic increase in the FDA‘s enforcement of regulations that deal with product claims and labeling. In an effort to be more pro-active, the agency has been investigating companies for compliance with the FD&C Act, particularly section 403(r)(1)(A), which deals specifically with product descriptions and claims. As a result, a number of companies have received warning letters — which are viewable online, damaging brand reputation — addressing the product claims made on their labels or websites.
PageFreezer: Your Best Defense
Since most marketing now happens via websites, social media, and other Internet tools, it is of utmost importance for your company to have a reliable, accurate archive of all online activity. Should your claims be investigated or questioned, defensible evidence of your website’s precise content is a necessity — and that’s exactly what PageFreezer provides.
Automated Archiving Daily
Using crawling technology, we take daily automated snapshots of your website. Only new pages or changed pages are archived, saving storage space. The whole process is automatic — you don’t have to remember to do anything. Just enjoy the peace of mind that comes with having your online records perfectly preserved.
Resources
Federal Rules of Evidence 901 — Data Integrity & Authenticity
FDA Compliance & Enforcement – Food
FDA Guidance Documents — Drugs
Code of Federal Regulations (CFR) Title 21 (with search functionality)
Model Requirements for the Management of Electronic Records (MoReq) (Europe)