Foreign Supplier Verification Program inspections of importers are in full swing. The first inspections began almost immediately after the May 30, 2017 effective date for entries from large foreign suppliers. FDA ramped up the number of inspections when the 2018 fiscal year began and continue to regularly inspect importers.
FDA’s mantra at the moment is to “educate while we regulate”. FDA officials say the goal is help bring importers into compliance, the same approach they say the agency is taking with producers. As of March 13, 2018, here are the latest enforcement statistics:
o For Fiscal Year 2017: 0 Official Action Indicated, (0 Warning letters), 179 Voluntary Action Indicated issued, (resulting in 174 483a issued), 106 No Action Indicated issued.
o For Fiscal Year 2018: 0 OAIs, 51 VAIs (each with a 483a issued), 33 NAIs
To date, all inspections have been pre-announced. As of early March 44,000 food importing entities have registered as an FSVP importer. Recently, Sharon Mayl, FDA senior advisor for policy, said there are six major observations FDA FSVP inspectors are finding:
Based on input from several importers, the typical FSVP inspection begins with an email from and FDA inspector in which he or she cites one or more entries by that importer and requests an appointment to review the records related to the entry and supplier. Some emails ask the following questions:
a. If a very small importer, please state your annual sales in the United States for your business over the last three years. (If you are classified as a very small importer you are exempt from most of the requirements of FSVP. In order to verify your status of very small importer, during the inspection, your firm must represent documentation showing your sales over the last 3 years.)
The email also says that if the recipient does not believe it is the FSVP importer for one or more of the cited entries (or for any food), that it should explain that belief in an email reply that includes a phone number so the inspector can follow up as needed.
Once the above questions are answered in the reply from the importer, the inspector will work to confirm a date for the inspection. In many instances, in the email confirming the inspection appointment the inspector will ask for information such as the number of employees in your firm, the square footage of your office/warehouse, percentage of wholesale and retail business of your frim, top three foreign suppliers (address included), top three domestic customers (address included) and the label for the product or products being reviewed.
Upon arrival the inspector will present his/her badge, a Form 482d that says he/she is there to review FSVP records ad oftentimes a fact sheet on FSVP. The inspector will then ask basic information about the company and then specifics about who is handling FSVP responsibilities. Of course, that person (or one of those people) should be the main contact with the inspector.
Inspectors also seem to be asking if the company has had any recalls or customer complaints of illness or injury that FDA has not been made aware of.
Inspectors will review the documents provided and will review the signatures on those documents. Some inspectors have advised that when keeping electronic records, an electronic signature or some other signature (as opposed to initials) is the best practice to show that only authorized individuals are actually reviewing those documents.
In early inspections, compliance dates were often a focus of the inspections. But with nearly all entries now subject to FSVP, that’s becoming less of a focus. Inspectors do take time, however, to review verification that a foreign supplier meets the criteria for modified compliance, such as a very small supplier or a producer of a product subject to HACCP regulations.
As noted above, FDA is finding a lack of compliance in areas such as a written policy to source from only approved suppliers, documentation showing suppliers have been approved and that a review of documents provided by third parties has been conducted.
The “educate while we regulate” mode is expected to continue through early 2019. After that point, stronger enforcement is expected. Additionally, importers should expect another FSVP inspection within five years unless an FDA inspection or product issue reveals the need for an inspection sooner than that.
FSVP inspections are entirely document-based. Importers won’t know what documents they need to have on file are putting themselves at great risk – not only from FDA but from customers who may not be comfortable sourcing from them.
The Food Safety Preventive Controls Alliance is offering a course on the FSVP rules. (It has courses on some other FSMA rules as well.) The FSCPA course offerings are the only ones with curriculum recognized by FDA. It’s strongly recommended all importers have at least one person take that course, whether offered through AFI or another entity.