FSMA Animal Food cGMP inspections have begun…

The following is an update CFD received from AFIA regarding inspections…

AFIA learns FSMA CGMP inspections are under way

Last fall, the Food and Drug Administration provided an update on its plans for investigator training for the “Current Good Manufacturing Practice and Hazard Analysis Preventive Controls for Animal Food” (PCAF) final rule inspections. The strategy is to develop a 30-person investigator cadre from FDA’s Center for Veterinary Medicine and Office of Regulatory Affairs and state regulators from 10 different states, who will conduct the first inspections, and in turn, train the rest of the inspectors. This 30-person inspector cadre will perform the majority of CGMP inspections during the first year of compliance.

Investigators are required to attend the 20-hour Food Safety Preventive Controls Alliance (FSPCA) training for preventive controls qualified individuals (PCQI), as well as an additional FDA regulatory training course prior to conducting any PCAF inspections.

FDA’s intention is to conduct CGMP compliance inspections only with “large” businesses in fiscal year 2017. A large business is defined in the final rule as a business employing 500 or more full-time equivalent employees. It’s important to note that FDA has stated not all “large” businesses will be inspected in FY2017, and the focus of the initial inspections will be on education, training and technical assistance to help companies comply with the new requirements.

The American Feed Industry Association learned [in mid-February] that one of the first CGMP inspections was conducted at a member facility in Georgia. The federal investigator was from FDA’s Atlanta District Office and had a list of facilities in the investigator’s area to inspect. During the inspection, the investigator emphasized to the plant manager the purpose of the inspection was focused on education at this point rather than compliance. Below is a summarized list of items that were asked for or discussed during the inspection:

  • Asked questions related to the size of the company
  • Asked for documentation of qualified individual training
  • Asked whether the facility has CGMPs in place
  • Asked whether the facility has conducted a hazard analysis
  • Asked whether the facility has a written animal food safety plan prepared
  • Asked whether the facility has an environmental monitoring program
  • Asked whether the facility has a recall plan
  • Asked whether the facility is an importer
  • Asked to see facility job descriptions
  • Asked questions pertaining to PCQI qualifications
  • Conducted a thorough walk-through of the plant to observe CGMP compliance

The investigator was clear to state that all of the questions were not related to actual current Food Safety Modernization Act requirements for the facility. The goal was to get a better understanding about where the facility is on its journey.

In addition to the official Notice of Inspection, the plant manager was left with FDA Fact Sheets on Mitigation Strategies to Protect Food Against Intentional Adulteration Final Rule (animal food is exempt from this regulation), Preventive Controls for Food for Animals Final Rule and Sanitary Transportation of Human and Animal Food Final Rule. The plant manager was told he would receive a full written report on the inspection at a later date.

AFIA notes many of the questions asked by the investigator are not related to the CGMP requirements. FDA appeared to be gauging the overall understanding of the final rule by plant management. For instance, no facility in a firm of more than 500 employees is required to have a recall plan until September of this year and only if that facility has one or more preventive controls. However, the facility did need to have records documenting qualified individual training, as that is required of first-year compliance facilities.


Used with permission by AFIA.