This article was originally published on September 3, 2020. It has been updated with new information.
Steven Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding, provided an extensive overview of FDA inspections during the May 28 Govilla webinar, “Guess Who’s Knocking At Your Door: Assuring Inspection Success!” Parts I and II of this series covered FDA’s authority to inspect, the types of inspections conducted, and what FDA investigators can and cannot review when onsite.
An Ounce of Preparation
So, FDA investigators are at the gate. What can you expect during the inspection? And how can you prepare in advance to ensure a smooth inspection?
Niedelman offered the following advice for how companies can prepare for an FDA inspection long before investigators are at the gate.
- Train the personnel responsible for access to the site, even security guards and receptionists, to inform the appropriate individuals that “FDA is here.” There should be a call down list with critical contacts. Front-facing personnel should be trained to tell the investigator to have a seat until somebody comes.
- Conduct mock audits to ensure staff members understand their roles in an inspection. For example, IT will need to set up conference rooms and computers for investigators.
- Keep organizational charts up to date.
- Ensure you have a current opening presentation about your firm that includes the floor plan and who is responsible for manufacturing product.
- Develop a demo of the product or device manufactured onsite.
- Make sure you have copies of current procedures available.
Once the investigators are onsite, ascertain the scope of the inspection. Is it a routine surveillance inspection? Or is it a for-cause inspection?
“It may start as a typical routine surveillance inspection,” Niedelman said. “Over time as things develop or [inspectors] find things, they may decide to focus in different areas. If it is a medical device firm, those inspections are typically preannounced three to five days in advance and you can ask the purpose of the inspection.”
Once you have the name of the investigator, Niedelman recommended looking up their profile in Govzilla along with asking your network about their experience with that particular inspector.
What to Expect During an Inspection
As discussed in Part I, the FDA investigator or investigators must issue a 482 Notice of Inspection to the individual in charge. Investigators are not entitled to inspect until issuing the Notice of Inspection.
During an inspection, investigators will typically commandeer a front room. They will spend most of their time here reviewing documents. This is the room where staff will speak to investigators and provide documentation.
What about site personnel? According to Niedelman, site personnel generally stay in a “back room” away from the investigators. This is the war room for site personnel (Niedelman refers to this as the “glue in an ongoing inspection”) where staff respond to requests from investigators and discuss how things are going in the front room.
The back room “is generally where you will go to get educated as to what is going on before you walk into that front room.”
Figure 1 compares front room versus back room activities.
Figure 1 Front Room versus Back Room
What Should You Do?
Niedelman recommended site staff do the following:
- Keep subject matter experts well-prepared
- Select a note taker
- Track documents sent to the front room by date and time
- Ensure all paper documents are tracked and keep copies of all papers given to the investigators
- Make sure all resources and supplies requested are available
- Listen carefully to all questions and only respond to those you know the answers to; if you do not know the answer, acknowledge the question and state you will get an answer
On the last point, Niedelman said that investigators will ask the same question in different ways because they want to ensure they are getting consistent answers. If personnel start giving different answers, investigators will suspect they are not getting the full truth.
[Author’s Note: For more about preparing for an FDA inspection, view this clip from the webinar.]
“Do not be lured into a false sense of friendship,” he added. “Everything that you say is on the record. It may not appear on the 483, but it could appear in the inspection report that the investigator writes up.”
The back room ‘is generally where you will go to get educated as to what is going on before you walk into that front room’
What Will FDA Do During an Inspection?
Along with asking questions, the investigators will want to review documents, spending considerable time on this task. Documents they will review include:
- Receipt and testing records of materials
- Incoming inspection records
- Production records
- Testing equipment records
- Equipment and maintenance records
- Standard operating procedures
In addition, the investigators will also want to visit the production floor.
“They will walk the floor to make sure that you are, in fact, following those procedures,” Niedelman said. “Typically, most investigators will do a walkthrough at the end at the end of the session to get a feel for what is going on and what is being currently manufactured. They will frequently pick a product and follow it—generally, the most significant product being manufactured at the time of their inspection.”
As the investigators review documents, they may come across procedures they think do not reflect what actually occurs during production. In this case, they may revisit the production floor to verify compliance.
This is where mock audits come in handy. An hourly worker on the production line will likely be nervous when questioned by FDA. By conducting mock audits of staff, personnel become accustomed to the process.
If the investigators take any samples from your firm, they must provide a form 484 Receipt for samples and offer payment for the samples at wholesale price once the inspection is completed.
Do not be lured into a false sense of friendship
Niedelman also warned against signing specific affidavits.
“Frequently they will attempt to obtain a signed affidavit to document distribution of a specific product and/or to document interstate commerce to establish their jurisdiction,” he said. “We recommend, as most law firms will, not to sign those affidavits. It is recommended that it not be signed and that you not allow them to read it to you. We have had clients that literally have walked out of a room where the investigator insisted on reading it.”
He added, “It is in your best interest not to sign those affidavits to document interstate commerce. You do not know what it is going to be used for. You do not know if it is just simply for jurisdiction or to document shipment of violative product. There is no requirement for you to sign.”
Part IV looks at what happens after an inspection along with some inspection do’s and dont’s.
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