Test Your Readiness for a DSCSA Inspection or Inquiry
July 5, 2015
In the event of a DSCSA compliance inspection or official verification inquiry, how can you ensure that your business will be prepared? Go through our preparation list to gauge your readiness and highlight areas of weakness that you may need to address.
Staff education
If an FDA or state official arrives at one of your locations, will your staff be up to the challenge?
- We have a designated point person for DSCSA compliance issues, and staff across all of our locations know who that person is and that they should be contacted in the event of an inspection or inquiry.
- We have a trained backup person in case our designated compliance lead is out of the office.
- We do not have a specific point person, but all staff has been trained on DSCSA processes and could respond to an inspection or inquiry.
- Our staff is aware that some verification inquiries have strict timelines and require a very prompt response.
- If questioned on information within specific T3 fields, our staff will be able to explain why any given data is or is not included.
Accessibility of compliance data
When your business needs to produce Transaction History, Information, and Statement (T3) data for either one designated product or product that matches a range of criteria, will you be able to access it?
- All of our compliance documentation is stored in one central repository, so we will not need to conduct separate searches in multiple systems.
- We have access to our compliance documentation across all of our company’s locations, regardless of where product was received or shipped. If an inspector arrives at any location, our staff will be able to pull up T3 for requested products, even if the products are or were physically located in a different location.
- We have access to our repository 24/7, without the assistance of IT staff.
- We can query our documentation repository, searching on a variety of different criteria (e.g., NDC, supplier, date range, lot number, or downstream partner).
Compliance data management
Are you able to manage and account for all of your compliance documentation, regardless of what format you receive it in?
- All compliance data is in electronic format. We do receive some paper documentation, but we have a means to convert it to an electronic format and store it with the rest of our T3.
- We are storing paper compliance documentation with no electronic backup, but it is organized in such a way that we can rapidly locate specific records.
- We are confident we can produce requested documentation quickly enough to respond to official verification inquiries with tight timelines.
Verification inquiry consequences
If an official verification inquiry results in the determination that you are in control of a suspect product, do you have the processes and procedure in place for the necessary follow up?
- We have documented processes in place for quarantining the product in question.
- We have documented processes in place to promptly conduct an investigation with our trading partners.
- We have documented processes in place for archiving the records associated with the suspect product inquiry for at least six years.
To truly test their readiness, some companies have run mock inspections, randomly selecting one product or products that meet certain specified criteria, and having their compliance point person produce the correct documentation. If you were not able to check off many items after reviewing this readiness list, or a mock inspection does not run smoothly, your business may want to reassess your compliance approach before a real investigator arrives on your doorstep.
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