MEDICAL DEVICE MANUFACTURERS WHO WISH TO SELL THEIR DEVICES IN THE UNITED STATES WILL BE SUBJECTED TO AN FDA INSPECTION TO VERIFY THAT THEIR QUALITY SYSTEM COMPLIES WITH FDA REGULATIONS.

The FDA has been increasingly aggressive about inspecting medical device companies over the past several years, and for start-up companies who have already gone through the painstaking process of securing venture capital, submitting a 510(k) application and beginning the manufacturing process, an FDA inspection could be the green light that moves your product into the marketplace or an obstacle that brings your operations to a halt.

The FDA publishes a publicly available manual called the QSIT - Quality System Inspection Technique - that guides FDA inspectors in conducting the inspection of your facility. Medical device manufacturers who wish to do well on an upcoming FDA inspection would be wise to familiarize themselves with QSIT, the most common deficiencies found in FDA inspections, and the relevant guidelines for medical device quality systems found in 21 CFR Part 820.

QSIT: THE DEFINITIVE GUIDE TO THE FDA AUDIT

When your company is visited by an inspector from the FDA, they will use the guidelines in QSIT to perform the inspection. You can access the complete QSIT guide here. Here are some of the main points that will be addressed within the inspection, along with some other information from the guide:

  • The inspection may be pre-announced, but the FDA inspector may also simply arrive one day without any warning.
  • The FDA will review five major items:
    • Management Controls
    • Design Controls
    • Corrective and Preventive Actions
    • Production and Process Controls
    • Sampling Plans
  • Other important requirements like supplier/purchasing controls, medical device tracking, corrections and removals, and sterilization fall into these broad categories - they will be rigorously inspected as well.
  • The FDA will review the results of your internal quality audits - if you are not doing them, you need to start.

THE MOST COMMON DEFICIENCIES FOUND IN FDA AUDITS

Each year, the FDA inspects thousands of medical device manufacturers for compliance with 21 CFR Part 820 and other legally mandated requirements. When the agency observes instances of non-compliance, it issues a Form 483 describing the issues that manufacturers must respond to and address in order to pass a subsequent inspection. The most common deficiencies found and reported during FDA inspections on Form 483 are:

  1. Procedures for corrective and preventive action (CAPA) have not been properly established.
  2. Procedures for reviewing and investigating complaints have not been established.
  3. Purchasing controls have not been established correctly.
  4. Processes used in manufacturing the medical device have not been validated adequately, so the manufacturer cannot possibly know if the process is yielding a non-conforming product.
  5. Written medical device reporting (MDR) procedures have not been developed or implemented.
  6. CAPA results have not been documented properly (or at all).
  7. Lack of procedures for controlling product that does not conform to specified requirements.
  8. Procedures for quality inspections have not been established.
  9. Complaints about device failures or issues with labeling or packaging were not investigated adequately.
  10. No procedures for training employees or identifying needs for training.

When the FDA issues a 483, medical device manufacturers have a very limited time to adequately respond and correct the issue, otherwise, they could face a shipping hold on their products and huge revenue losses, not to mention the cost of getting the quality system up to date.

GREENLIGHT GURU HELPS YOU AVOID FDA AUDIT DISASTERS

Greenlight Guru's quality management software (QMS) can help you organize your quality system and streamline FDA inspections, saving you time and money in the process. With Greenlight Guru's cloud-based QMS, your documents are securely stored in the cloud where they can be electronically accessed by an FDA inspector. Document and version controls help ensure that your quality documents are all up-to-date and accessible when you need them, and a paperless QMS ensures that nothing is inconveniently missing on the day of your inspection.

As a result, your QMS can be inspected by the FDA in significantly less time, and you'll avoid the inconvenience and expense of fighting the FDA over their Form 483 observations or worse, a warning letter.

Are you interested in learning more about our Quality Management Software? Let’s take Greenlight Guru on a demo.

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