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INTRODUCTION
FDA has broad authority to inspect any facility that manufactures, processes, packs or holds medical devices. FDA may inspect, without a warrant, any such facility at reasonable times, within reasonable limits, and in a reasonable manner. Moreover, some FDA inspections are unannounced, making advanced preparation necessary to ensure that the process goes smoothly.
The following checklist is designed to highlight some critical aspects of that preparation. It is not legal advice and is certainly not a substitute for obtaining formal legal guidance. Hopefully, however, it can help companies begin thinking about their current state of inspection preparedness. In essence, the checklist can help answer an important question: If an FDA investigator arrived today, would your company be ready?
Does Your Company Understand The Scope Of FDA's Inspection Authority?
The first step in preparing for an inspection is to consider the scope of FDA's inspection authority. As noted above, the grant of authority is generally very broad. By statute, FDA may enter and inspect at reasonable times, within reasonable limits, and in a reasonable manner, any facility or vehicle where medical devices are manufactured or held. This grant of authority raises a number of questions that need to be considered by a company before an investigator arrives.
1. What is the definition of reasonable as applied to you company?
The determination of whether an inspection is "reasonable" depends on the circumstances. For instance, a 3 A.M. inspection may be reasonable if the facility has a production run at that time. As a result, to prepare for an unannounced inspection, a company should discuss with its regulatory counsel what would be "reasonable" with regard to the company's specific circumstances. Similarly, during an inspection, the company should discuss with its regulatory counsel whether the conduct and manner of the inspection is reasonable in light of all the circumstances including the purpose of the investigation and the seriousness of the potential problems.
2. What is an FDA investigator allowed to do during an inspection?
When considering the particulars of what an FDA investigator has authority to do during an inspection, it is useful to think in terms of three categories:
Category 1: What An FDA Investigator Generally May Inspect
Generally, an FDA investigator may inspect:
o all vehicles used to ship or hold product
o all pertinent equipment
o finished and unfinished materials
o containers
o labeling
o all records required by applicable good manufacturing practices or quality systems regulations
For all restricted devices (all PMA devices are designated by FDA to be restricted devices), an FDA investigator may also inspect:
o records, files, papers, processes, controls and facilities bearing on whether such products are adulterated or misbranded
Category 2: What An FDA Investigator Generally May Not Inspect
Generally, an FDA investigator may not inspect:
o financial or sales data (other than shipment data)
o pricing data
o personnel data (other than information regarding the qualifications of technical and professional personnel)
o most research data
o internal audit reports (not including records demonstrating that the audits were conducted in accordance with the company's schedule)
o minutes of management review under 21 C.F.R. � 820. 20(c), but may see the records submitted to management for the review. See 21 C.F.R. �
820.180(c); 820.100(a)(7).
Category 3: Unsettled Issues Requiring A Company Policy
For all products, the authority of an FDA investigator to take pictures during an inspection is unsettled. Therefore, it is important for a company to consult with its regulatory counsel to develop a policy with regard to photography during inspections. Similarly, on occasion, FDA investigators will request that company employees sign affidavits during an inspection. Again, a company should consult with its regulatory counsel to develop a policy with regard to such affidavits. Both of these policies should be incorporated into the company's standard operating procedure (SOP) for FDA inspections, discussed in greater detail below.
Has Your Company Designated An Inspection Team?
Once a company has an understanding of the scope of FDA's inspection authority, it should work with its regulatory counsel to develop an inspection procedure. The purpose of the procedure is to avoid panic and disorganization when an investigator arrives. Instead, every member of the staff should know exactly what his or her role is in the inspection process.
The first step in developing an inspection procedure is to designate a three-person inspection team. The members of this team will be the company's liasions with the investigator. They will serve as escorts, scribes, and contact people during an inspection. The inspection team will be responsible for developing a working relationship with the investigator, will document each day of the inspection and will ensure that the investigator receives appropriate access. To perform these roles, all members of the inspection team must be knowledgeable about the facility, products and regulatory compliance.
Has Your Company Adopted An SOP For FDA Inspections?
To ensure that the inspection process goes smoothly, it is critical to have a detailed standard operating procedure. The SOP should:
1. List the members of the inspection team
2. Set the procedure for responding to the arrival of an investigator including:
o notifying the following personnel immediately:
- inspection team
- corporate headquarters
- regulatory counsel
o advising all personnel that an inspection is in progress
3. Delineate the procedure for developing a relationship with the investigator while setting boundaries including:
o being courteous at all times
o cooperating with the investigator to the extent possible, but politely disagreeing when appropriate
o requiring that all requests from the investigator go through the inspection team
o requesting an agenda for the inspection and attempting, if possible, to limit the scope of the inspection to that agenda
o escorting the investigator at all times
o limiting the investigator's access to the records, facilities, and materials that are subject to inspection
o following the company's policies regarding photography and affidavits
4. Create a system for documenting the entire inspection including
o
o keeping a daily log of
- all employees interviewed
- the investigator's focus for that day
- the questions asked during the interviews
- the documents copied
- the samples collected
- the tone of the investigator
o making an extra file copy of every document copied for FDA
5. Delineate the procedures to be followed at the end of the inspection including
o if applicable, asking to review a draft of a 483
o requesting a closeout meeting with the investigator
o if the investigator takes any samples, requesting
- a report of the results of FDA's analysis
- a portion of the sample to conduct independent analysis
o preparing a report of the inspection
o if applicable, procedures for responding to a 483 or warning letter
o following up with the District Office
Has Your Company Trained All Of Its Personnel To Follow The SOP?
An SOP is only effective if all personnel understand and follow it when faced with the pressures of an inspection. All personnel, not just the inspection team, need to be trained on how to proceed during an inspection. After all, an investigator's observations and conclusions are not limited to the inspection team.
CONCLUSION
A company need not dread the appearance of an FDA investigator. If it understands FDA's inspection authority, creates an inspection team and trains all personnel to follow a detailed standard operating procedure, it can ensure that it will be ready to handle even an unannounced inspection. Although the arrival of an FDA investigator may never be a welcome sight, preparing in advance can make the inspection process far less daunting.
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