Import+Q-and-A

Proper Documentation for Import Issues
Here a few tips. With respect to import issues, if you send an email to the SPL account (SPL@fda.hhs.gov), please indicate in the subject header (in no specific order):

1. If this is an urgent issue – please mark urgent only when it really is…if you anticipate an import issue, please send FDA a message as early as possible so they will have adequate time to research the issue and reply to your message 2. That it is related to an import issue 3. The specific product/s for which you are requesting assistance

In the body of the message, provide any additional details that will help FDA research the issue as quickly as possible. Please don’t email the SPL account and Lonnie as he gets the message twice and has to reconcile them to make sure they are the same. FDA is doing all it can to get the import staff trained but until this occurs (and there are a lot of people that must be made aware of the changes so it won’t happen immediately), they recognize that companies may need their assistance to resolve some of the import questions that arise. Hopefully these tips will help.

Useful Supplementary Documentation for FDA Inspections involving SPL/eListed products
Good to have a recent D&B report on hand for FDA inspectors. Recently, one company had to supply a D&B report to support a Doing Business As Name during an FDA Inspection. In the past DBA names were listed on the FDA 2656 form; however, this is no longer part of the electronic Establishment Registrations. The D&B report will have this information.

Documentation/Escalation for Holds on Imports Somehow Related to SPL
Who you are: Sponsor information (company name, contact person) What was affected: Shipment information (product with application number/Review Division as appropriate, NDC codes, port of entry, hold time, date when hold started, reason(s) as communicated by the Inspector and/or the sponsor contact any information about financial impact)
 * Include:**


 * Address to:**

To Michael A. Chappell, Acting Associate Commissioner for Regulatory Affairs, ORA [michael.chappell@fda.hhs.gov ] + District Office(r) [copy DRLS contact(s) as appropriate]

“We filed electronic registration and listing files for establishment [last update date] and product(s) [last update date]. [Product or Bulk Substance] has been held at [Port of Entry] since [Date]. The FDA Import Inspector has requested [type of information]
 * Letter text example:**

We are concerned. We have followed proper procedure according to FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing. Our data is on file with the DRLS group as part of the eList submission. For some reason, the port inspectors are unable to access and retrieve the current electronic data. By requesting paper documentation, we are being asked to submit possibly out-of-date establishment and drug listing information, instead of the current data present in the eList system.

Since we submit this data electronically as documentation of our establishments and products, and the data is available to staff in the DRLS group, we are surprised that the Inspectors at [Port of Entry] do not have similar access. The inability of the Inspectors to quickly and easily access the data already provided to the FDA by [sponsor] is holding up our [Product/API] supply.

[closing statements about contacting sponsor for any follow-up, etc.]

Note: For issues involving CBER products and SPL imports/listings/registrations issues, copy vada.perkins@fda.hhs.gov. He is the SPL point-of-contact for CBER.