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How to Avoid Major FDA Inspection Mistakes

FDA has decreased the length of time between inspections in recent years, thus requiring medical device companies to be prepared to accommodate the inspector’s more frequent visits and quickly respond to possible findings.

In 2008, Class II manufacturers were inspected once every five years, and U.S. Class III manufacturers once every three. Then the political environment changed, and FDA’s funding resources increased. Now FDA is required by statute to inspect U.S. Class II and III medical device establishments once every two years. FDA spent most of 2009 recruiting, hiring and training new inspectors. By 2010, the agency increased the number of inspections by 25% (2,550 in 2009 and 3,174 in 2010).

This article focuses on the three biggest mistakes that companies make during an FDA inspection. For further resources, the FDA inspection manual, QSIT, is available online.

Mistake #1: Responding in >15 days

OEMs fear FDA because FDA has the ability to take legal action against a company and its managers if the company is not compliant with regulations. Usually, failure to comply results in the issuance of 483 observations, and the company must respond by implementing CAPAs to address each observation. The worst possible mistake a company can make is to fail to respond to a 483 observation within 15 business days. Therefore, make sure you confirm which days the inspector considers business days. If FDA receives your corrective action plan in 16 business days, it will not even open your company’s response. Instead, the agency will automatically issue a warning letter.

Immediately after an FDA inspection, the management of your company should establish a team to address each of the 483 observations. This team must do the following in less than 15 business days:

  1. Contain (i.e. quarantine) nonconforming product or materials associated with the observation—if any. If affected product has left the direct control of the company, correction and removal (i.e. a recall) may be required. (1st business day after inspection)
  2. Implement corrections for each observation. This may be done in parallel with the investigation(s). (1st business day after inspection)
  3. Assign investigation responsibility to one person, with appropriate qualifications and authority, for each observation. (2nd business day after inspection)
  4. Investigate each observation using one or more root cause analysis tools and document your investigation in each CAPA record. (3rd business day after inspection)
  5. Identify the root cause of each observation, and document the root cause in each CAPA record. (6th business day after inspection)
  6. Develop a corrective action plan that is reasonable, and that you can complete in an appropriate amount of time. Procedural changes should be made in days or a few weeks, while process and design changes may take months to revalidate. For lengthy corrective action plans, major milestones should be identified. (8th business day after inspection)
  7. Have an independent expert review each of your corrective action plans within 24 hours. This expert should be aware of the potential need for this service as soon as you are notified of FDA’s request to inspect your facility. The expert may be an internal expert or an outside consultant—depending upon the size and resources of your company. (10th business day after inspection)
  8. Make final revisions and edits to the corrective action plan and send it to FDA—using overnight delivery and with signature confirmation. (12th business day after inspection)

Mistake #2: Talking too much
FDA inspectors are trained to interview people in order to gather the most amount of information. One of the most popular interviewing techniques is to pause and say nothing after the interviewee has answered a question. The silence is uncomfortable for most people, and interviewees will typically offer more information in the hopes of satisfying the inspector. This is a huge mistake.

FDA only knows what you tell them and what they are able to gather from the FDA database. In addition to your company’s website, this information includes:

  1. Medical Device Reporting (Form 3500/3500A)
  2. Corrections & Removals (i.e. recalls)
  3. Registration & Listing
  4. 510(k) Submissions
  5. Previous Inspection Reports

During your internal audits, internal auditors should identify any employees who are too talkative and not comfortable with silence. FDA should be steered away from these employees. Employees who handle silence like a stone statue should be identified as the preferred individuals to speak with FDA.

If FDA asks for a specific record associated with an MDR, the person who provides this record should provide the record and identify the various documents that comprise the record. The person should not explain the record or attempt to justify any gaps in the record, because FDA is probably not aware of what is missing from the record—unless it is included in the MDR.


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