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When an Inspector Calls

Following a checklist of important action items and implementing a detailed organizational plan will help you successfully navigate a visit from the FDA.

John Gagliardi • Contributing Writer

It’s the compliance equivalent of having a dentist show up at your house to give you a root canal (or at least it seems that way)—a U.S. Food and Drug Administration (FDA) inspection. Not a problem, you say? You’re organized and prepared. That’s a good start, but even the most steadfast planning may not be enough. Sometimes, companies that are truly compliant and have effective quality management systems (QMS) are a disappointment from the minute the FDA inspector walks into the lobby to the turbulent exit meeting. Other companies have mediocre systems in place and handle FDA inspections brilliantly.

Managing an FDA inspection properly is imperative to realizing success from a logistical standpoint as well as to staying on top of potential compliance-related challenges.

Over the years, a number of procedural trends have suggested the “dos and don’ts” of preparation for a number of the inspection’s most important variables, for example: the arrival of the inspector; employee and management involvement; managing the inspector; interviewing and constructive answering techniques; handling documentation; defining proprietary information; the use of a “mission control” room; follow-up; and follow-through. Let’s face it; the dynamics of having a complete stranger enter the inner sanctum of your company to inspect what your employees have completed involves seemingly innumerable factors. There is so much involved with just managing these logistical variables without taking into account that your company must always put the best possible objective evidence in front of the inspector.

This is serious stuff, but there’s no need to panic. Implementing a series of carefully outlined procedures will help you successfully handle an FDA inspection.

A Few Key Definitions

Before getting started, there are a few key points everyone involved in an inspection should be aware of.

Section 704(a) of the Food, Drug, and Cosmetic Act gives FDA the authority to conduct good manufacturing practice inspections of medical device manufacturers. During these inspections, facilities, manufacturing processes records, and corrective action programs are examined by an FDA investigator. The results provide information necessary to evaluate a manufacturer’s compliance with the device quality system (QS) regulation (21 CFR 820).

Anyone who manufactures or stores a medical device can be inspected. A manufacturer is any person who designs, manufactures, fabricates, assembles or processes a finished device. A manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributor(s) of devices from foreign entities performing these functions.

Early Strategy

It is true, unfortunately, that some inspections are unannounced. For the most part, however, FDA inspections—depending upon your relationship and history with the agency’s district office—are conducted with prior notice. Announced or not, there should be a coherent strategy and procedure in place (that everyone—yes, everyone—at the company reads and can understand) to managing FDA inspections. It’s not a matter of luck and chance that your company will be a winner at the end of an inspection.

A planned, premeditated approach is a good start when the FDA-483 (notice of inspection) is presented. Some company executives claim they are ready every day to defend themselves during FDA inspections—which means “bring it on.” That type of false bravado rarely spells success. In fact, that style of approaching an investigator usually means just the opposite. Because the business is running smoothly and you’re making money doesn’t mean that your QMS is in compliance. In addition, it surely doesn’t mean that your employees are inspection-savvy and ready.

Investigator’s Arrival

Investigators should arrive at the main lobby of the facility. At no time should the investigator be allowed access to any part of the building other than the lobby area without a company escort. In cases where the investigator arrives at another entry or access point other than the lobby, the investigator will be escorted to the main lobby of the facility until the arrival of the appropriate coordinator or escort personnel. After ensuring the investigator is in the lobby, the receptionist or other company employee approached by the investigator will contact the president, management representative and/or the director of regulatory. Make sure the investigator remains in the lobby until either one of these people arrives and escorts the investigator into the building. Company personnel are never required to receive FDA investigators at their homes.

A management representative or regulatory executive should be appointed to coordinate the inspection; meet with the investigator to confirm identity and determine the purpose of the visit; and ensure that all pertinent information generated in the inspection is collected, indexed, filed and maintained by the control room coordinator for a time period deemed appropriate.

Conduct During the Inspection

Awareness of what is going on at all times by the contact person of the manufacturer during the inspection is important. Therefore, once started, the inspection should be given priority. If the contact person is distracted by other business, the inspection may be prolonged and the investigator’s questions concerning suspected deficiencies may be misunderstood or answered inadequately. Familiarity with the circumstances surrounding any deficiencies listed on the FDA-483 (the list of deviations presented at the close of the inspection) is vital in discussion of these digressions with the investigator.

If there are questions for which you don’t have immediate answers, promise to research the questions. A list of the unanswered questions is a reminder to get the answers and give them to the investigator. The investigator usually records the questions, and resolving unanswered questions may help avoid inaccuracies on the FDA-483 and in the establishment inspection report prepared by the investigator at the end of the inspection.

While the inspection is being conducted, ensure that theinvestigator only has access to information and documents as specified in document, information and sample requirements.

Assemble copies of documents requested by investigator, if allowed, and make sure that all requested documents be marked as “confidential.” In every case, forward requested documents to the control room first and then to the investigator, if allowed. This can be best explained as a screening process before initial viewing by the inspector. No documents or records should enter the FDA Room unless initially reviewed, copied, recorded and released. The management representative should ensure that a copy of these requested documents are retained for at least five years under document control.

Other important procedures or tasks for key staff to be aware of during the inspection include:

• Ensuring the investigator complies with all applicable quality system requirements (e.g., safety glasses, safety procedures, etc.).

• Notifying the investigator—if he or she should ask for product samples (R&D, production or finished samples) that the agency may be billed for any samples. All samples will be marked as such prior to issuance.

• Ensuring duplicate same-lot, same quantity samples are selected so testing can be performed by the company. Make sure the samples are retained for seven years.

• Contacting the president and the regulatory representative if the investigator requests product testing be performed.

• Requesting that the investigator directs questions only to designated individuals or representatives of the area being inspected.

• Ensuring the documentation or synopsis of all significant discussions between the investigator and company personnel.

• Clarifying any incomplete, misleading or inaccurate information given to the investigator.

• Ensuring daily inspection updates are conducted with company leadership and communicating those updates to appropriate and applicable customers.

• Ensuring periodic and timely updates are filed by the regulatory department.

• Ensuring the management representative, the president, and regulatory professionals all are on call for the duration of the inspection.

After the Inspection

Once the inspection has ended, the company’s inspection point-person should schedule an exit meeting for the investigator and the company’s top-level management. The meeting usually is held immediately after the inspection, but may take place a day or so later, especially if it takes a long time to prepare the FDA-483. During this meeting, the investigator discusses with company management the observations recorded on FDA-483 and other observations not listed that he or she wants to bring to management’s attention.

The manufacturer should compare the FDA-483 against notes taken during the inspection to confirm the accuracy and completeness of the investigator’s recorded observations. Close-out meetings present a chance for all parties to correct misunderstandings. Inaccurate observations will be changed or deleted as appropriate.

Top management should be present at the close-out meeting to provide information regarding any planned corrective actions to be taken and schedules for these actions. At the conclusion of the meeting, obtain the inspection findings report, FDA-483—if issued—from the investigator and escort the investigator from the facility. This also is the time to inform the applicable and appropriate customers of the inspection results.

Completion of the inspection should signal the start of certain activities by the manufacturer, if these activities have not already been initiated, such as discussion of deficiencies with appropriate department employees to advise them of corrections to be made and time frames involved.

Unresolved FDA-483 items should be reviewed by companytechnical and legal personnel. If a decision is made that corrective action is not needed and there is disagreement with the investigator’s opinion regarding the deficiency, state this along with the rationale and documentary evidence, in a letter to the FDA district officeresponsible for the inspection. Even if a manufacturer agrees with all the items on FDA-483, it is a good idea to respond to each item ina letter to the district office, along with documentation showinghow the corrections have been implemented. The response to the

FDA-483 observations should include system corrections and not just “putting a bandage” on the specific observations. It is very important that the root cause is investigated and determined (if possible, of course), that deficiencies are corrected, and that appropriate preventive actions are instituted. This reply shows a commitment to quality assurance and “officially” presents the company’s case to FDA. This reply should help resolve any doubts that the inspection report might raise.

The final step for a manufacturer is to determine the lessons learned from the inspection so the business can operate in a better state of control, improve quality assurance and assure future QS compliance.

Parting Comments

It is imperative that the company responds to any recommendations or observations made by the FDA investigator or other official. A written response to the FDA-483, along with documentation to show how the company has or intends to remove or correct the objectionable conditions or practices, can assure the FDA that the firm has corrected or intends to correct the listed violations. The company should prepare such a response even if it does not hear from the FDA in writing. Remember that a plan of corrective action is very important. Management should evaluate the FDA-483 and the management letter. If they feel any misunderstanding can be resolved by discussion, they also may request a meeting with the FDA’s district management to discuss violations and the company’s proposed courses of action. Thisprovides a first-hand opportunity to present the case to the FDA.

John Gagliardi is president of MidWest Process Innovation LLC, a company he founded in 2000. A veteran of the medical device and pharmaceutical industries for more than 40 years, Gagliardi’s career has included active involvement in the areas of research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. He is a third-party auditor for ISO 13485 and 21 CFR, Parts 820 and 211. He is a U.S. agent and official correspondent to more than 20 companies worldwide. MidWest Process Innovation offers training in design controls, handling FDA inspections, purchasing controls, CAPA, quality auditing, cGMP-QSR and ISO 13485:2003. Gagliardi can be reached at (513) 573-0085 or

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