FSMA Inspections have begun…

Large companies (more than 500 employees) were required to be in compliance with cGMP’s in September of 2016. For most CFD members the date for compliance is September 2017 and this is just around the corner. FDA inspections of large companies have begun and smaller companies can benefit greatly from the information provided to industry on what these inspections look like.  CFD is a member of American Feed Industry Association (AFIA) and receives regular feedback on inspections and the types of questions being asked. The following is a summary and contains excerpts from the information provided by AFIA.

AFIA Excerpts are in italics.

“Dianne Milazzo, consumer safety officer in the FDA Center for Veterinary Medicine, made a presentation to the Washington State Feed Advisory Committee, of which the American Feed Industry Association is a member, on April 20. She briefed the committee on inspectors and inspections to date:

  • The inspector cadre has been assigned 250 inspections to be conducted between February and Sept. 30.
  • These inspections will cover large firms in segments of the animal food business from feed manufacturers, pet food manufacturers, ingredient supplier segments and pet food warehouses.
  • As of April 19, 35 inspections had been conducted.
  • Only one notice of adverse findings form (Form 483) has been issued–for lack of effective measures to reduce pests–in a pet food warehouse.
  • Other items that have been noted but not written up formally include:
    • Sanitation issues;
    • Trash/harborage areas on the outside of buildings; and
    • Unshielded lighting in processing areas over exposed product.
  • 32 of the 250 inspections have been assigned under state contracts:
    • Five states have these contracts–Iowa, Kansas, Minnesota, Missouri and North Carolina.
    • In other instances, an FDA inspector may bring along a state inspector to help educate the state staff and ultimately achieve a consistent approach to conducting inspections.
  • While the sanitary transportation regulations are in effect for large firms, inspection likely will not start until the new fiscal year, after Oct. 1. FDA is working on a path to incorporate the sanitary transportation inspection into the CGMP inspection assignment, and inspectors will need to receive training.”

What to expect when they inspect!

One of the first inspections was held at a plant in Georgia. The FDA investigator emphasized to the plant manager the purpose of the inspection was focused on education. AFIA summarized the following 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. 

AFIA members have shared additional information and AFIA has the following comments regarding the information and requests.

“One item AFIA has been hearing is the inspectors are asking to see complaint files as part of their inspection. It is important to note the final animal food rule did not mandate facilities to keep a complaint file, nor did it mandate review of those files as part of your verification activities (80 FR 180, page 56265). In reality, most animal food facilities or corporations have a procedure in place to accept and review complaint files. This is a requirement for licensed medicated feed mills under 21 CFR part 225.115, but only for the drug portion of products.”

“AFIA reminds members to know what FDA has the authority to review and copy during an inspection. In general, its authority is very limited, and non-medicated feed inspectors only have the authority to inspect and copy labeling. Other circumstances for the inspection will broaden their authority to inspect and copy records.”

“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.