Knock knock. Who’s there? The FDA.
It’s no joke. The passage of the Food Safety Modernization Act (FSMA), signed on January 4, 2011, signaled an increased focus on food safety by the United States government. One way that increased focus has manifested itself over the last several years is a big increase in the number of inspections performed by the FDA. As the FSMA is implemented over the next several years, food, beverage, and dietary supplement companies must be sufficiently prepared to deal with what was, at one time, a possibility, but is now a not-too-distant reality – an FDA inspection.
The FDA has focused much of its attention on compliance with the current good manufacturing practices (CGMP) for foods and dietary supplements. Regulations governing the CGMPs for dietary supplements were issued in 2007 with a final deadline for small companies to be compliant by June 2010. Since then, the FDA has made compliance with CGMPs on of the top priorities in the regulation of dietary supplements. However, it’s not just dietary supplement companies experiencing an increase in attention towards manufacturing compliance. The bulk of warning letters issued to food, beverage and dietary supplement companies over the last several years have addressed alleged manufacturing compliance issues, including observations made during inspections of seafood companies for compliance with Hazard Analysis and Critical Control Point (HACCP) regulations, alleged insanitary conditions in bakeries and cheese manufacturing facilities, and, of course, the alleged non-compliance of dietary supplement manufacturing facilities.
With the passage of the FSMA in January 4, 2011, inspections have increased 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.
Thus, if you are a company in the food industry, an inspection is almost certainly coming to your place of business in the near future. Well-organized companies will be in the best position to handle an inspection and get through it as quickly as possible. Following are some tips for handling an inspection as efficiently and painlessly as possible.
The foundation for a well-prepared company is to devise solid procedures for an FDA inspection. Company personnel should be identified that will be the established contact or contacts with the 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 the CGMPs have been a clear focus of recent inspection activity, knowledge of and careful compliance with the CGMPs is critical. Organized record-keeping 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 inspectors to be on the company’s premises.
When the FDA appears for an inspection, counsel experienced with the FDA should be put on notice immediately so that they are available to answer any questions if necessary. The designated persons that will be responsible for communicating and coordinating with the 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 the 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, the FDA is given the authority by statute to inspect facilities at which food is manufactured, processed, packed or held and refusal to allow the 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 that they can properly ensure the FDA’s adherence to those limits.
Once the investigation is over, the FDA will often issue an FDA Form 483. The FDA Form 483 identifies the perceived violations that an FDA inspector may observe during an inspection. While there is no statutory obligation to do so, companies should respond comprehensively to the observations in the FDA Form 483 or they run the risk of receiving a warning letter. Additionally, companies must provide support for their responses, including evidence of changes. Recent warning letters have been issued to companies that the FDA deemed had provided inadequate responses to the issues identified in the FDA Form 483.
Most important of all, and this cannot be emphasized enough, DO NOT LIE TO FEDERAL AGENTS, including the FDA! There are countless stories of people who were guilty of relatively minor violations and 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. 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 easier than you can from a jail cell.
Justin J. Prochnow is an attorney and Shareholder in the Denver office of the international law firm of Greenberg Traurig LLP. His practice concentrates on regulatory and legal issues affecting the food & beverage, dietary supplement and cosmetic industries. He can be reached at (303) 572-6500 or email@example.com and is on Twitter at @LawguyJP.
This article is issued for informational purposes only and is not intended to be construed or used as general legal advice. The opinions expressed are those of the author exclusively.