The “early alert” memorandum on FDA’s lack of an efficient, effective recall-initiation process that was issued by the Office of the Insp… … Continue readingOIG Report Turns Up the Heat on SPeed of food RecallS

In last week’s newsletter, we provided an overview of FDA’s new Voluntary Qualified Importer Program (VQIP) final guidance and what it me… … Continue readingWriting Your VQIP QAP: What is Required?

It’s finally here! For all those who import food and have been waiting and wondering if you qualify for the Voluntary Qualified Importer … … Continue readingYou Can Now Expedite Entry of Your Imported Foods … If You Meet All Eligibility Criteria

It’s unlikely to be a surprise to anyone who receives this newsletter that noroviruses are the most common cause of epidemic gastroenteri… … Continue readingDo You Know What To Do When a Norovirus Incident Occurs in Your Facility?

While the arrival of the first of the FSMA compliance deadlines brings with it the need for enforcement, FDA’s discussion of “What’s Next… … Continue readingIn the Midst of FSMA Guidance Issuance, FDA Discusses “What’s Next”

In the second half of Chapter 4 of the Preventive Controls Draft Guidance, FDA focuses on suggestions and recommendations for identifying… … Continue readingWhat Does FSMA’s Guidance Say about Sanitation Controls, Food Allergen Controls and Recall Plans?

Focused specifically on Preventive Controls, Chapter 4 of the PC Rule Draft Guidance is intended to help industry identify, implement, an… … Continue readingWhat FSMA’s Guidance Says About Process Controls as Preventive Controls

It is October of an even-numbered year … which means it’s time for the biennial renewal of your facility registration in FDA’s Food Facil… … Continue readingIt’s Time to Renew Your Facility Registration … and Ensure Your Category is Correct

For the last couple weeks, TAG has delved into the opening chapters of FDA’s draft guidance for the Preventive Controls rule. This week, w… … Continue readingPC Guidance How To #3: Identifying Potential Hazards

As we noted in our last newsletter FDA has published various guidance documents recently, and we are continuing our review of these this w… … Continue readingA Guidance How To: Conduct Your Hazard Analysis