FDA News Update
See the Exemptions to the Proposed Rule for Preventative Controls for Animal Food
The charts below do not contain all of the information necessary to determine the proposed requirements for compliance in a particular circumstance. Consult the proposed…
FDA Form 483 Response Strategy – FY 2012 Inspectional Observation Summaries
FY 2012 Inspectional Observation Summaries FDA Form 483 response strategy – perhaps the best strategy to both prepare for a
Electronic and Radiological Devices Accession Numbers
Electronic and radiological device accession numbers are one of several parts of bring a radiation emitting product to market. Accession numbers refer to the unique FDA identifiers for…
Tobacco Health Certificate (NCTTP)
The tobacco health certificate will be one of two submissions for newly regulated tobacco companies (vape, e-cig, e-liquid, cigar, hookah, etc.). These certificates must be…
Walmart VTA Supplier Requirements
Selling with a major retailer is a dream for many companies. When selling with any major retailer it is important to understand the retailer’s regulatory…
Amazon FDA Registration Proof
Amazon FDA registration proof can be a moving target. Is it a certificate, a screenshot, or something else!? The answer varies from week to week…
FDA New Tobacco Deadlines
As is well known by now the FDA Deeming Regulation is effective as of August 8, 2016. What is less well understood are the various…
FDA Enforcement and Recall Report Week of July 18
FDA Recalls Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the…
FDA Enforcement and Recall Report Week of July 11
FDA Recalls Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the…
FDA New Tobacco
FDA new tobacco regulation also known as the Deeming Regulation takes effect in 30-days (August 8, 2016). The regulations are broad, complex and impact every…