A Tale of Two Inspections

I recently spoke with two feed mills that I have worked with in different capacities over the years. Each has recently had a FSMA inspection. Without divulging the identity of either mill I would like to summarize the key parts of each inspection:

#1 – FDA conducted this inspection just prior to the March 2020 COVID pause.

  • Our FDA Investigator was very thorough. He first read through all our programs and then toured the Mill Operations. 
  • Next, he came back and started going through records to match up with what we said we were doing in our programs.
  • He was very meticulous in matching up employee training records and what our CGMP program said we would train for. 
  • He then looked for records to see if the individual that was trained had filled out documentation according to our plan.
  • He concentrated on our CGMPs and their supporting pre-requisite programs. 
  • He focused in detail on our pest control program. Looking for trending reports and recommendations by our pest control technician and our own internal walkthroughs.  He did his own physical inspection and found no issues.
  • He was also very interested in all training that was done by our company.
  • He looked at “Sanitary Transportation”: training records, testing, and certificates of completion.
  • He looked at our Hazard Analysis, Flowcharts, and Feed Safety Program and no deficiencies noted.
  • “All in All… it was not a bad experience.” 

#2 – PA Department of Agriculture conducted this inspection in December 2020 on behalf of the FDA. It was a combined inspection for VFD, non-licensed medicated feed and CGMP’s. It did not include Hazard Analysis and Preventive Controls. 

  • For the VFD inspection he selected 3 random orders and went over the paperwork in detail.
  • For the non-licensed medicated feed inspection, he reviewed all our required medication logs.
  • He had notes from a previous state inspection and went over the issues identified in that previous inspection to determine if recommendations were corrected.
  • He asked a long list of questions about CGMP’s and took notes on my answers.
  • He then toured the entire facility from top to bottom to confirm we are doing what we say we are doing. 
  • He focused on housekeeping and pest control. We do pest control ourselves and he was looking for records.
  • He was very interested in any, and all logs we keep.
  • He asked about training since we have had several new employees recently.
  • Although it was not the purpose of this inspection, he asked if we had begun our Hazard Analysis and if we are working on our Feed Safety Plan. He indicated that the state has contracted with FDA for a very limited number of these inspections, but we can expect one in the next couple of years.
  • He was here for about 4 ½ hours.
  • “We have not received our report yet, but I feel it went better than I had anticipated”.

It is difficult to comment on the differences in the inspections because the purpose of each was different. There are similarities and for the most part they included all the elements that we were told to expect from an inspection. Both mills felt like the “educate while they regulate” was indeed what they were doing. They hope this information is helpful.

Veterinary Feed Directive Training Tools

January 1, 2017 marked the beginning of an expanded list of drugs that fall under VFD regulation. Click here to watch an FDA’s overview video on this rule and its importance to the industry.

CFD’s membership in AFIA affords us the opportunity to offer our membership valuable training tools offered to AFIA members.  Due to high demand, AFIA created a training module on VFD preparedness, which targets retail distributors (i.e. farm stores and co-ops), something previously unavailable.

  • Click here to watch the AFIA youtube training video.
  • Click here for an example of a completed VFD.

 Used with permission by AFIA.

Preparing Producers and Feed Sales Staff for VFD

On Jan. 1, 2017, certain antimicrobial drugs of human medical importance will change marketing status from over-the-counter to Veterinary Feed Directive (VFD). The American Feed Industry Association supports the judicious use of antimicrobial drugs and is working to ensure members are prepared for the upcoming change. AFIA is notifying members of new resources available to help ensure all groups are fully prepared to comply with the VFD rule.

Through recent efforts within the industry, there have been many resources and trainings for veterinarians and feed distributors. Much of this information has not been disseminated to the small producers and feed distributors, however. The Farm Foundation, NPF has partnered with the Animal Health Institute (AHI) to develop educational resources for producers, feed distributors and veterinarians. The first resource is a website containing educational materials from various sources.

The Farm Foundation and AHI have a campaign to inform farmers and ranchers of the pending changes. Information is disseminated through a series of informational radio interviews circulated through the news service of the National Association of Farm Broadcasters.

A point-of-sale card has been created, which is designed to alert producers of the Jan. 1, deadline and the need to prepare. The card refers people to the website for more detailed information. It can be placed in the feed section and/or at a checkout counter and is available in three formats:

  1.   Prints one card
  2.   Print two cards per page

Word file of the information, to which the retailer can add a company name and/or logo; can also be copied into an email message.

Used with permission by AFIA.

VFD is just around the corner…

CFD recently sent information on requirements for FDA notification and supplier acknowledgements. There are a number of information sessions being conducted by various organizations. When members have attended those they have provided additional information to CFD and we appreciate that… The following is noteworthy…

  • Documentation required for a VFD can only be stored electronically when in compliance with Federal Rules known as Part 11. This is essentially a secured server environment. CFD recommends that all documentation be maintained on paper initially. AFIA is working with the FDA to eliminate this mandate and we will keep you posted.
  • VFD cannot provide for automatic refills. The time period is limited to 6 months.
  • Pulsing regiments are not permitted.
  • To use Bovatec in conjunction with a VFD drug the VFD must include that direction.
  • Record retention requirements for documentation vary by state. Federal requirements are 2 years.

Veterinary Feed Directive (21 CFR Part 558) goes into effect 12/31/16. Are you ready?

“Over the past several years, the FDA has taken important steps toward fundamental change in how medically important antibiotics can be legally used in feed or water for food-producing animals. Now, the agency is moving to eliminate the use of such drugs for production purposes (i.e., growth promotion and feed efficiency) and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians – changes that are critical to ensure these drugs are used judiciously and only when appropriate for specific animal health purposes. The Veterinary Feed Directive (VFD) final rule is an important part of the agency’s overall strategy to ensure the judicious use of medically important antimicrobials in food-producing animals”.

As a feed manufacturer or a store that sells medications fed to animals that fall under this law what do you need to do?

Step 1: Identify the medications, combinations, premixes and products that require a VFD. At the 2016 CFD annual meeting Dr. Eric Reid presented a list of the most common drugs used by members that will now require a VFD:

– Apramycin

– Chlortetracycline

– Erythromycin

– Gentimycin

– Hyrgomycin B

– Lincomycin

– Neomycin

– Oleandomycin

– Oxytetracycline

– Penicillin

– Spectinomycin

– Streptomycin

– Sulfachloropyrazine

– Sulfadimethoxine

– Sulfamethazine

– Sulfaquinoxaline

– Tetracycline

– Tylosin

– Virginiamycin

This list is not all inclusive, some have trade names, some are part of a product where the other ingredient doesn’t need a VFD, but those products will still need a VFD. Be diligent in finding out which products will need a VFD. See below for more information from CFD to define these requirements…

 Step 2: Register with the FDA: There is a one-time registration requirement. To comply, send a letter to the FDA stating that your company is a distributor or animal feed products under 21 CFR part 558 Veterinary Feed Directive. Include: your company name and business address; signature and date of at least one owner. Mail the notification to:

Food and Drug Administration

Center for Veterinary Medicine

Division of Animal Feeds (HFV-220)
7519 Standish Place
Rockville, MD 20855          or faxed to: 240-453-6882

 Step 3: Define a process for obtaining and retaining VFD documents. Key components of this process should include:

  • Obtaining the VFD prior to manufacturing the feed.
  • VFD must be written and signed by a Veterinarian.
  • It can be a paper document or sent electronically.
  • It can be delivered by the Veterinarian, Customer or a Nutritionist.
  • Must contain specific information: Refer to this website for details: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm455415.htm
  • Can only be used for the specified time period.
  • Must be retained for 2 years.

Step 4: Train employees: All employees who receive and process orders must be trained in this requirement.


More Information:

CFD Commonly Ordered Items:

Item # Description Item # Description
1100010 Aureomycin 4 g  5 lb. 1800654 Tylan 40
1100034 Aureomycin 4G  50 lb 1800411 Neo/Terra 10/10
1104042 AS 700 2g 1800006 Aureomix S 10/10
1104046 AS 700 3.5g 1800005 Aureo SP 250
1800651 Aureomycin 100 1104038 Terramycin 4 g
5575320150 Scours & Pneumonia Treatment Concentrate 50# 1104044 CTC 10 g
0232123 Scours & Pneumonia Treatment Concentrate 20# 1800648 Aureo 50
5575320239 Scours & Pneumonia Treatment Concentrate 4.34# 1800649 Aureo 90
1117530 Scours & Pneumonia Treatment 6.4 oz 1100020 Aureo 20 g
1127530 Scours & Pneumonia Treatment 6# 1800688 Sulmet 12.5% liquid
2500101  CFD 20-20 AM with OTC  (to be discontinued by MFG) 1800576 Terramycin Scour tabs
1800656 Tylan 10