More updates…

Inspection Statistics:

This summer AFIA published the following statistics on inspections completed in FY2019 (October 2018 – September 2019):

 FY 2019 CGMP*FY 2020 Plan CGMPFY 2019 HA/PC*FY2020 Plan HA/PC
Domestic Inspections964
311 FDA
676 State
180 FDA
409 State
178 FDA
56 State
360 FDA
95 State
# of Violations
(Form 483)
75 VAI*
9 OAI*
28 VAI
16 OAI
* Current Good Manufacturing Practice
* VAI (Voluntary Action Required)
* OAI (Official Action Required)
* HA/PC (Hazard Analysis and Preventive Controls
 FY 2019FY 2020 Plan
Sanitary Transportation9584
Expect that inspections will be stacked meaning they will combine CGMP and HA/PC with FSVP, Sanitary Transportation of Food, Medicated Feed CGMP, BSE and VFD inspections as applicable to the facility. The more types of inspections your facility is subject to may increase the likelihood of inspection.

With most of our member feed mills being on NY and PA, it is worth noting that NY Department of Agriculture did not contract with the FDA to perform inspections, but PA Department of Agriculture did contract to do both CGMP and HA/PC. In my opinion, PA members may expect inspections sooner if they have not already been visited but it may take some time for NY to see significant inspections…

Then Came COVID-19:

As we all know by late March of 2020 everything changed as COVID-19 forced the world to “pause”. Our industry is of course essential and had to do its part to keep moving as if the world was “normal”. The FDA briefly halted inspections other than for cause indicating immediate threat to health and safety. Inspections resumed on a very limited basis in July 2020. All inspections are being scheduled so precautions can be taken during the visits. Some work is being done virtually to limit direct contact.

What is next???

Next month, I will attend a virtual conference of FSPCA Lead Instructors for FDA recognized courses in CGMP’s, HA/PC and FSVP. We expect presentations from many sources including the FDA. As with everything else the focus will be on the impact of COVID-19. I will certainly share what I learn. If you have any questions regarding the impact of the virus on your operations, please reach out to me, so I can try to get answers. There will be a breakout session specifically for Animal Food. There will also be a presentation to provide us as lead instructors more information on opportunities for virtual training as the pandemic plays out in the next year.

Training Opportunities:

Winter 2021 may be an opportunity to provide a virtual (or very small in person) Part B of the Blended Hazard Analysis and Preventive Controls for Animal Food. If you, or any of your Feed Safety Team, needs this training, please let me know. If you have taken Part A, you normally must complete Part B within 6 months. This window has been extended due to lack of course availability.

New tools have been released:

 In October FSPCA released an “Abbreviated Guide to Creating a Livestock Food Safety Plan Under the Preventive Controls for Animal Food (PCAF) Rule”. I am in the process of reviewing this guidance and the included example feed safety plan. More information will be forthcoming.

Finally, some reminders from the FDA…

Facility Registration Deadline is December 31, 2020

Have questions on Facility Registration? See my post on November 8th for an FDA FAQ document to get answers…

Getting a flu shot is more important this season than ever before!

November 18, 2020

The FDA wants to remind the millions of men and women on the front lines of growing, processing, preparing, selling and delivering food for both people and animals, to get their seasonal flu shot.   

The Centers for Disease Control and Prevention and the healthcare community are preparing for flu viruses and the virus that causes COVID-19 that will spread this fall and winter. Both are contagious respiratory illnesses, but they are caused by different viruses. One of the most important differences is that there is a vaccine already available that can protect you against the flu. While getting a flu shot will not protect against COVID-19, a flu shot will protect you by reducing your risk of flu illness, hospitalization, and possibly death. Protecting yourself from the flu will also help save medical resources for the care of COVID-19 patients. 
People who have flu often feel some, or all, of these symptoms:

  • fever or feeling feverish/chills
  • cough
  • sore throat
  • runny or stuffy nose
  • muscle or body aches
  • headaches
  • fatigue (tiredness)
  • some people may have vomiting and diarrhea, though this is more common in children than adults.

The best time to get a flu shot is now before the flu begins spreading in your community. It takes about two weeks after getting a vaccine for antibodies to develop in the body and provide protection. 

The same factors that contribute to workplace and community spread of COVID-19– including prolonged close contact with coworkers, congregate housing, shared transportation, and frequent community contact among workers—likely contribute to the spread of the flu. 

When an essential worker gets a flu shot, they protect themselves, their families, co-workers, and their communities. Healthy workers help to ensure the availability of a safe and nutritious food supply. 

To learn more about how and where to get a flu shot, contact your employer or visit:

Flyer for the Workplace (PDF: 2.19MB)