Global Regulations: Preparing for FDA Facility Inspections

If you are a company providing services or manufacturing products regulated by FDA, that next knock at your door could be an FDA inspector. With continued emphasis being placed on food safety, highlighted by the passage of the Food Safety Modernization Act (FSMA) signed on January 4, FDA has earmarked more resources than ever before to conduct inspections of food facilities. As the FSMA is implemented over the next several years, companies must be sufficiently prepared to deal with what was, at one time, a potential occurrence but that will soon become a distinct certainty.

The marked increase in the number and frequency of inspections is evident through a review of FDA’s database of Warning Letters. Through May 31 of this year, FDA posted 269 Warning Letters. Of those 269 warning letters, 208 of them cited violations that were discovered during inspections of food and beverage, supplement, medical device, and drug facilities.

Topping the list of most frequently alleged violations are violations of Current Good Manufacturing Practices (cGMPs) and, in particular, the cGMPs for dietary supplements. The final deadline for small companies to be compliant with the cGMPs for dietary supplements passed in June 2010. Since then, FDA has conducted many inspections to access compliance. There has also been a noted increase in Warning Letters issued as the result of inspections of seafood companies for compliance with Hazard Analysis and Critical Control Point (HACCP) regulations. On the heels of the widespread publicity surrounding the abhorrent conditions existing at several Iowa egg farms last summer, dairy and egg farm operations have been inspected for unsanitary conditions. Even several airline catering facilities have received Warning Letters in 2011 after being inspected.

As the provisions of the FSMA are put into action, inspections will only increase in frequency and scope. Among the many facets of the FSMA, there is a new inspection mandate imposed on the FDA. The legislation requires inspections to be based on risk, and further requires the frequency of inspections to increase as well. All high-risk domestic food facilities are to be inspected within five years of the bill’s signing, and then at least once every three years after that. Further, all other domestic food facilities are to be inspected within seven years of the bill’s signing, and then at least once every five years thereafter.

In a speech at George Washington University on May 19, Michael Taylor, Deputy Commissioner for Foods at FDA, discussed FDA’s change in conducting inspections. “Historically, FDA’s inspectors have inspected food-processing facilities for basic sanitation and to detect visible problems with the facility or the product being produced. Under FSMA’s new norm, FDA inspectors will still be looking for what’s gone wrong, but they will also be looking to verify that firms are implementing the systems needed to do things right.”

If you are a company in the food industry, an inspection is almost certainly coming to your place of business in the near future. So what should you do? To borrow from the Boy Scouts: “Be Prepared!” Well-organized companies will be in the best position to handle an inspection and get through it as quickly as possible.

The foundation for a well-prepared company is to devise solid procedures for an FDA inspection. A company should identify which of its personnel will be the established contact or contacts with FDA. While the identified personnel will have the primary responsibility of interacting with the FDA inspector and addressing questions, each employee should be aware of how to conduct business during the length of an inspection. Once the procedures are devised, a mock run-through of an inspection is advised to see whether the procedures stand up to the test.

As cGMPs have been a clear focus of recent inspection activity, knowledge of and careful compliance with cGMPs is obviously critical. Organized recordkeeping and the establishment of SOPs (Standard Operating Procedures) will help facilitate an inspection. The less time spent gathering information and compiling records during an inspection, the less time necessary for the FDA inspector to be on the company’s premises.

The designated persons responsible for communicating and coordinating with FDA inspectors must know the laws and regulations pertaining to inspections. The FDA Investigations Operations Manual (IOM), the primary procedure manual for FDA personnel performing inspections and special investigations, is available on FDA’s website. The IOM is a great resource and contains valuable information and insights as to how FDA personnel are directed to conduct inspections. For example, FDA is given the authority by statute to inspect facilities at which food is manufactured, processed, packed, or held, and refusal to allow FDA to inspect is a criminal offense. That right to inspect, however, is not unfettered, and the persons accompanying FDA personnel during the inspection should know the limits of those inspection rights so they can properly ensure FDA’s adherence to those limits.

Once the investigation is over, FDA will often issue an FDA Form 483. Form 483 lists the alleged violations that the FDA inspector identifies during the inspection. A company must comprehensively and sufficiently respond to the observations in the Form 483. Recent Warning Letters have been sent to companies FDA deemed had provided inadequate responses to the issues identified in the Form 483.

Most important of all, and this cannot be emphasized enough, do not lie to federal investigators! There are countless stories of people guilty of relatively minor violations who made their situations exponentially worse by trying to cover them up. Lying or providing materially misleading information to any federal government agent while he or she is performing official duties is a felony. As my mother used to say, “I may be unhappy with what you have done, but the consequences will be a lot worse if I find out the truth after you have lied to me.” Do not turn a minor labeling violation into a criminal action! At the end of the day, you can address any issues uncovered during the course of an inspection from the friendly confines of your office much more easily than you can from a jail cell.