An Important Issue to Address

Consistency. We all strive for it but it’s absolutely crucial when listing your facility’s address with FDA, other government agencies and entities used to carry out compliance tasks with government agencies.

Using the Association of Food Industries as an example, I know we often list our address a few ways:

• 3301 Route 66, Suite 205 Building C (the way we were told to do it)
• 3301 Route 66, Suite 205C (shorter; we still get everything)
• 3301 State Route 66 . . . (GPS lists it that way)
• Probably a couple of more

We’ve found recently that staff at a food facility handling its address in a similar way is opening itself up to some issues. For example, all facilities that are required to be registered with FDA also need a DUNS number from Dun & Bradstreet. (That’s a somewhat new requirement for foreign facilities; see my July 11 blog for more on that.) We’re finding that once a DUNS number is issued, the address can’t be changed – even if it involves a minor change such as the example I listed above would necessitate. The work-around people are doing is cancelling out their FDA registration and filing a new one with the same exact address as in the DUNS number filing.

That’s extra work and can lead to delays, depending on when the filing takes place. Of course, there are other times facility information is provided to FDA and others. Take the time to ensure your firm’s standard operating procedures spell out the need to be consistent when providing an address.

A couple of other points:

• These number are facility-specific, if your firm has more than one production facility, you’ll need one for each location. For importers with more than one facility, you’ll only need a DUNS numbers for offices/locations where the records and the qualified individual(s) are located. So, if your firm has more than one office but anyone who meets the definition of a qualified individual is in one of those offices and can access all the needed records, you likely would need only one DUNS number and you would provide the DUNS number for that location.
• Think about emails provided on filings as well. Many are using a generic email such as compliance@abcfoods . . . so that personnel changes don’t create problems and absences due to illness or vacations don’t lead to unanswered emails. It’s no fun when you can’t submit required information because you’re writing from an email address that’s different than what’s on file and/or you don’t know the password because the person who submitted the information is no longer with the company and you can’t reach him/her.

Providing correct and consistent contact information is a must. Just imagine the frustration for an FDA investigator who shows up at the wrong location because of misinformation you provided; not a great way to start an inspection.