Category: Inspections

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.

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.

Large companies (more than 500 employees) were required to be in compliance with the first parts of the rule in September 2016. What did that mean in terms of FDA inspections? As one might expect, it has been a slow start and there have not been inspections to date. The FDA is focused on training inspectors (31 had been trained as of early December 2016). They are working with states to contract inspections as well and we expect that New York and Pennsylvania will do so. So what are they doing? FDA Consumer Safety Officer Jenny Murphy spoke at a conference held by AFIA in Arlington, VA in early December. She spoke about the inspection efforts by the FDA and what to expect moving forward.

Key points made:

• Only inspections in FY17 will be for compliance with CGMPs for “large” businesses
• Other facilities that get inspected (for BSE or medicated feed CGMPs) can expect to be asked FSMA readiness/awareness type questions. Answers are voluntary but very helpful to FDA staff.
• Inspections expected to start January 2017
• FDA will NOT inspect all “large” businesses in first year

She answered the following questions:

• Does the focus on education mean the FDA will NOT hold companies to these standards right away? No, while the focus is on education a public health threat will move inspections to action.
• What is the best thing a facility can do to prepare? Take the intent of the rule to heart, look at big picture and look past the regulation… Document, document, document!
• Where can companies go wrong in preparing? By putting the focus on passing the inspection and NOT putting food safety in the forefront.
• What is the ultimate goal of the FDA? The ultimate goal is food safety and public health.