It may also be the company's first chance to demonstrate to FDA its compliance with FDA regulations, especially compliance with current Good Manufacturing Practices ("cGMPs"). On the other hand, a poor inspection can lead to difficulties including more frequent inspection. Federal law grants FDA authority to inspect food and nutraceutical manufacturers and distributors upon providing written notice (called a Form 482) and showing appropriate credentials. FDA inspections may be unannounced and without a warrant, so long as the inspectors show up at a "reasonable" time. Key components of an effective plan include: (1) understanding the scope of FDA's inspection authority; (2) designation of the company's "inspection team"; (3) having written Standard Operating Procedures (SOPs) for an inspection; and (4) personnel training for what to do (and what not to do) during an inspection. Scope of FDA's Authority The scope of FDA's authority during an inspection of a nutraceutical company is broad, but not unlimited. Generally, FDA may inspect:
Finished and unfinished materials;
All records required by applicable good manufacturing practices.
Just as important however, is understanding what materials FDA may not review during an inspection. Generally, FDA may not review:
Financial or sales data (other than shipment data);
Personnel data (other than qualifications for technical/professional personnel);
Research data; and
Internal audit reports (though not records indicating audits were conducted in accordance with the company's SOPs).
Therefore, it is important to keep records FDA may lawfully review separate from those records they may not. Thus, it is a good idea to have a separate room or area where FDA records are kept. It is also worth noting that FDA does not have specific authority to take photographs during an inspection. Nevertheless, FDA inspectors often attempt to take photographs and a specific policy should be drafted regarding the taking of photographs during an inspection. Designation of An "Inspection Team" The first step any nutraceutical company should take to prepare for an FDA inspection is to designate an "Inspection Team." This Team will be responsible for developing the procedures for dealing with an inspection and during any inspection should act as the company's liaison with the inspector. At least one member of the inspection team should accompany the inspector at all times, as well as document the inspection. Drafting Effective SOPs For any nutraceutical company the most critical aspect of preparing for an inspection is having written SOPs that address the procedures that should be followed during an inspection and training employees to follow them. A company's SOPs should:
Designate the members of the "inspection team";
List immediate actions taken at the arrival of an inspector - who gets notified (inspection team, corporate officials, regulatory counsel);
Show how to interact with the inspector - being courteous and cooperative, but understanding when it is appropriate to say no;
Properly document the inspection from the company's view - keeping a daily log of who and what the inspector interviews or reviews, as well as documenting what records FDA requests;
Address procedures for the end of the inspection - reviewing a 483, close-out meetings, signing of affidavits, preparing inspection reports;
Address timeframes for responding to 483s or warning letters if necessary.
All Personnel Training Written SOPs are only effective if personnel are properly trained to follow them. While the main responsibilities during an inspection will fall on the inspection team, all personnel should be trained on these procedures to understand how to proceed during an inspection. For example, all employees should know to direct all inspector requests through the inspection team, and that they should be polite but not volunteer information to the inspector. Conclusion With proper training a nutraceutical company should not fear an inspection from FDA. By understanding FDA's authority for an inspection and having in place procedures and trained individuals, any company can be prepared. Nathan A. Beaver is senior counsel in Foley's Washington D.C. office, and is a member of the firm's Public Affairs and FDA Practices, and the Food Industry and Life Sciences Industry Teams.