FDA Provides Update on FSMA Inspections


The following is an update on the number and type of inspections of Animal Food Facilities have been completed by the FDA as of July 11, 2019. The remaining planned inspections are slated to occur between now and the fall (end of Federal Fiscal Year).
 
1.) CGMP by FDA – 136 complete of 250 planned
2.) CGMP under state contract – 222 complete of 371 planned
3.) HA/PC by FDA 51 of 150 planned
4.) HA/PC under state contract 12 of 68 planned
5.) FSVP by FDA two of 25 planned
6.) Sanitary Transpiration – 20 of 45 planned
 
Inspection findings continue to to include (in no particular order):
1.) Lack of keeping accurate records
2.) not maintaining equipment and buildings in a clean and orderly manner
3.) Improper labeling feed intended to be reworked
4.) Ineffective pest control.
 

AFIA Shares what its members have learned from CGMP Inspections…

American Feed Industry Association (AFIA)  is very active in FSMA education and outreach. They continually survey members to learn more about ongoing FSMA inspections. CFD’s membership in AFIA affords us the opportunity to share their findings. The following are excerpts of information they recently shared. I hope you find it helpful as you prepare for your facility inspection.

Continue reading “AFIA Shares what its members have learned from CGMP Inspections…”

Small Business FSMA Compliance date has arrived

Today is the day we have all been working towards.

  • If you are a CFD member who has participated in the CFD FSMA Program you are well on your way towards this compliance (assuming you are working on implementing the program we developed).
  • If you have taken the FSPCA Preventive Controls for Animal Food Course (taught by CFD or others) you learned that today is the day you are required to be in compliance with training (Sub-Part A) and cGMP’s (Sub-Part B). The  course explained many of the things you need to do.
  • BUT IF

Continue reading “Small Business FSMA Compliance date has arrived”

FDA Draft Guidance for Industry Current Good Manufacturing Practice

In August of 2016 the FDA released Draft Guidance for Industry Current Good Manufacturing Practice.  I have written previously that AFIA submitted 13 pages of comments on the 36 page document and that I was reluctant to discuss this draft document because of some of the  things it contains.  It is a year later and the compliance deadline is upon us (September 2017) but the guidance is still in draft form! It does not look like anything will change so it is time to move on…

Continue reading “FDA Draft Guidance for Industry Current Good Manufacturing Practice”

FSPCA Preventive Controls for Animal Food Introduction

I am a lead instructor for this course (Certificate#2ca42a12). Below are chapter summaries from this very important training. This training is recognized by the FDA as one way to become a Preventive Controls Qualified Individual (PCQI). As an instructor I feel it is an excellent way to become fully versed in the rule and obtain training necessary t implement the rule. I encourage owners, operators, agents in charge of a facility and the person to be designated as the facility PCQI to attend this training.

This class is highly interactive and each chapter has exercises and in some cases small group activities. You will not complete a FSP for your facility during this class but you will gain the knowledge on how to do so when you return to your facility.

Chapter 1

Regulatory Overview and Introduction to the Rule – This chapter goes over Sub Parts A, D and F in detail. It addresses important definitions and roles, the training requirements of the rule, exemptions and records requirements.

Chapter 2

Current Good Manufacturing Practice – This chapter defines the purpose and importance of cGMP’s. It explains the basic requirements of the 8 cGMP’s, which are the baseline standards required to manufacture safe feed. They provide the foundation on which you will write you Food Safety Plan (FSP).

Chapter 3

Animal Food Safety Hazards are described in this chapter. The hazard analysis process is described defined what to consider in this process, how to identify hazards by species and a general awareness of the biological,  chemical (including radiological) and physical hazards in animal food.

 Chapter 4

Food Safety Plan is defined in terms of required and optional elements. Example FSP’s are included in the curriculum. re described in this chapter.

Chapter 5

Hazard Analysis, and Preventative Controls Determination – in this chapter you will learn how to conduct a facility specific hazard analysis including how to the access the severity and probability of a hazard and to determine if a hazard requires a Preventive Control.

Chapter 6

Required Preventive Control Management Components – this chapter describes the steps you must take to manage the Preventive Control if you have one.

Chapter 7 – 9

Defines in great detail Process Controls, Sanitation Controls and the Supply Chain Applied Control.

Chapter 10

Recall Plans – defined with examples.

Caution:

There are many organizations offering PCQI training throughout the country and this will grow over time. If you are considering attending training, make sure it is for the Animal Food Industry and that it is certified by FSPCA. Not all training is certified.

Editorial Comment:

As of July 2017, we are starting to see opportunities to take this training virtually via your computer. I have taught a class virtually and I do not recommend it for the following reasons:

  • Distractions associated with not leaving your work environment Unless you can go to a place outside the mill this is difficult to overcome.
  • Due to the interactive nature of the labs, virtual environment makes this difficult to accomplish.
  • Ability to network with others in the industry and share concerns and ideas is diminished.

Unless you have extensive HACCP background or a third party certification at your facility I do not recommend this method of delivery.

FSMA Compliance Dates and cGMP’s

Animal Food Rule 21 CFR 507

The sub parts of this rule that you need to comply with are based on the activities you perform in your business:

  • Manufacturing – if you are manufacturing feed or feed ingredients you must be in full compliance with FSMA. In reality, if you manufacture, you are probably also processing raw materials and you certainly package them either in bag or bulk for sale.
  • Processing – There may be some facilities who do not manufacture finished feed or feed ingredients but process raw ingredients such as drying, cracking or grinding corn or crimping oats. These activities also require full compliance with FSMA.
  • Packing – If a facility only buys bulk feed or ingredients and packages it for further distribution, this activity also requires full compliance with FSMA.
  • Holding – If a facility only buys feed or ingredients and holds it in a warehouse for further distribution, much like CFD and a retail store, this activity requires limited compliance with FSMA.

What does full compliance and limited compliance require?

 

Sub Part Title Manufacture / Process / Pack Hold BY       
A General Provisions (training) YES YES 9/17/17
B Current Good Manufacturing Practice YES YES 9/17/17
C Hazard Analysis and Risk- Based Preventive Controls YES NO 9/17/18
D Withdrawal of a Qualified Facility Exemption NA NA NA
E Supply Chain Program YES NO 9/17/18
F Records (as they apply to above) YES YES As above

Sub Part B – cGMP’s – there is eight categories of cGMP’s that are considered to be necessary to the manufacture of safe animal feed. These are the foundation from which everything is built upon. This is where you start to: “say what you do and do what you say”.

In order to gain compliance with FSMA you should consider writing standard operating procedures (SOP’s) that demonstrate or document your compliance with cGMP’s.

  1. Personnel – defines employee rules regarding hygiene and sanitation.
  2. Plant and Grounds – maintenance of your facility and pest control.
  3. Sanitation – housekeeping procedures and the handling of toxic materials required to maintain sanitary conditions.
  4. Water Supply and Plumbing – water, plumbing, sewage and trash disposal procedures.
  5. Equipment and Utensils – procedures for the cleaning and repair of equipment, calibration of equipment.
  6. Plant Operations – includes purchasing, receiving, storage, processing and manufacturing.
  7. Holding and Distribution – includes packing, storing and shipping.
  8. Holding and Distribution of human food by-products for use in animal feed – process definition from packing, storing and shipping specific to human food by-products.