What you need to know before an FDA visit
What your company needs to properly develop, document and implement before an investigation
All food processors in this country manufacturing foods, other than meats and poultry, are subject to inspections by the US Food and Drug Administration.
Agency investigators can enter a processing facility at any time when the company is operating—day or night. This means processors must have someone on each shift who understands how to work with the FDA.
These individuals must know and understand the following:
- How to work with investigators
- Records available to investigators
- Rules for sample collection
- Photography policies
- Where to access procedures and records
- The regulations under which the investigators are working
- The names and qualifications of your Preventive Controls Qualified Individual (PCQI).
To ensure an FDA inspection is handled properly, it is imperative procedures are in place to do so. This means a program must be properly developed, documented and implemented, including training the staff on these procedures.
First, receptionists or those meeting and greeting visitors must understand that FDA can visit the plant. They also should ask for identification, share company rules including the company photography policy and immediately contact the person or persons who understand how to work with the agency.
FDA investigations may be conducted by FDA investigators or state inspectors, as the agency has established working relationships with many states to do these inspections. Also, there might not be only one investigator, but a team that can go in different directions during the inspection.
The company’s FDA liaisons should sit down with the investigators to review what will be evaluated and what documentation is needed. Investigators will ask for the food safety plan and look for how the company defends it, including validation data for any process preventive controls. They’ll want to talk with the PCQI, as this individual is responsible for developing and validating all process preventive controls and reviewing monitoring and corrective action records. In addition, they will want to look at prerequisite programs and go into the facility to verify that what is on paper is being done. The trained individuals and your PCQI will be expected to defend the plan.
Those company personnel working with the FDA should know what documents may be viewed. With the passage of the preventive controls regulations, FDA has access to more records than it did in the past, such as your food safety plan, hazard analysis, risk assessment and records for monitoring all preventive controls, sanitation preventive controls, allergen preventive controls and supplier preventive controls.
Documents to prove your PCQI is competent will also be needed, for instance, a PCQI certificate or other proof the person is qualified.
Also, the food safety plan should address environmental monitoring, even if your plan and products are such that environmental monitoring is not deemed necessary.
One bone of contention between regulators and the industry is the right to take photographs. Most FDA investigators carry cameras, and some are determined to use them, no matter what a processor says.
Food processors should establish a strict no photography policy, which should address cell phones, as these all have cameras. This policy should be posted in the lobby.
If the investigators insist on taking pictures or if their paperwork includes a warrant allowing them to take pictures, the company needs to have a policy to address this with instructions for plant personnel to remind the agency that any pictures that include trade secrets must be classified as secret. Elements of this policy should include clearly identifying trade secrets and ensuring that they do not end up available through the Freedom of Information Act.
Take your own pictures, including something in them to provide perspective, whenever FDA takes a picture. Some companies still use and feel safer with film cameras for pictures included in an investigation, as film cannot be easily edited or changed.
The agency may also collect product samples and swabs while in the plant. If this is done, processors should collect duplicate samples, ask what tests will be done and send duplicate samples to a third-party laboratory. Any tests should be conducted using recognized or official methods.
It is very likely that the investigators will observe one or more violations. Hopefully, the FDA people will point these out during the course of the investigation. If this does occur, make an effort to correct the issue as soon as possible and be sure to point this out to the investigators. They will still include the issue on their final reports, but may also indicate that the issue was corrected to their satisfaction.
The agency will send a formal report a short time after the investigation, and it is up to the company to address each issue cited on the report. One way to get yourself into hot water with the agency is to tell FDA that something was addressed, and it was not.
Be sure that your company is ready for an FDA investigation before it happens. Remember to properly train and educate all persons who might be involved with an investigation. If your company has already created such a program, be sure to review it in light of the preventive controls regulation.
One more thing to keep in mind: I recently received an email from a colleague whose facility had been the object of a FSMA audit by the FDA. The email said the inspection was similar to a Global Food Safety Initiative (GFSI) audit and that companies experienced with “that type of audit should be well prepared.” Also, the note said having a solid food safety plan and being PCQI trained are musts.
GFSI audit schemes include SQF, BRC, IFS or FSSC 22000. The language in the ISO 22000 scheme states the food safety management system must “conform with both statutory and regulatory requirements and with mutually agreed food safety requirements of customers.”
So, if you have taken the time and made the effort to achieve one of the GFSI audit schemes, you may well be ahead of the game, and implementation may be easier.