07.2.2019 Robert Fenton

FDA Audit: Medical Device Companies Should Watch Out for These 7 Mistakes

If you’re losing sleep to nightmares about an unannounced FDA raid on your company, then it’s time to get proactive. You should be prepared for an audit at all times.

You are not the first medical device manufacturing company to worry about or face an FDA audit. Instead of laying awake at night, learn from others who have gone before you.

Make sure that you aren’t repeating your past mistakes or the mistakes of others. To help you, we’ve compiled this list of the most common mistakes companies make during an FDA audit along with our tips for avoiding them.

FDA Audit: Medical Device Companies Should Avoid These 7 Mistakes

If you know what to expect, an FDA audit shouldn’t be a cause for alarm and resorting to “tricks” to disguise problems. The guidelines and requirements exist for a reason, and your company should devote the resources it takes to ensure that you are always compliant with regulations.

With the right processes, employee training, and tools, you can easily avoid problems like these.

NOTE: If you've already received a 483 letter from the FDA, check out our newly revised eBook: 5 Considerations for Responding to an FDA 483 Letter.

1. Being Lazy on CAPA

Insufficient CAPA procedures are the number one trigger for FDA citations among medical device companies.

In a 2014 presentation, Joseph Tartal of the FDA explained the essentials of effective correction and preventative action. One compelling point is:

“Manufacturers should consider that their corrective action and preventive action documentation can demonstrate to FDA that the manufacturer’s quality system is effective and enables the manufacturer to identify problems quickly and implement effective corrective and preventive actions (or not).”

To help you comply, the FDA also makes its own inspectional guide a matter of public record. You can easily review the specific objectives that investigators use when evaluating your CAPA system and its related documentation.

Related Reading: The 6 Most Common Warnings for FDA 21 CFR 820 Noncompliance

2. Talking Too Much

When the FDA asks a question, you should answer ONLY that question without any additional embellishment. Inspectors will often use long pauses to see if you'll start talking again so they can get additional information from you.

When answering questions, keep the following in mind:

  1. Listen carefully until he/she has finished their question, pause, and then formulate a proper response that you can deliver with confidence.
  2. If you are unsure of the question, don’t be afraid to ask for clarification.
  3. Only answer what was asked. Provide a clear, concise, and honest answer.
  4. Answer questions only if they are within your job responsibilities. Otherwise, direct their question to the appropriate subject matter expert.
  5. Do not try to be evasive or uncooperative with the investigator. Let them control the conversation and lead the agenda.
  6. Be decisive with your language and avoid using terms like typically, normally, generally, and usually.
  7. Avoid answering “What if…?” or other hypothetical questions.
  8. Don’t refuse requests that are appropriate, but where possible, try to at least narrow their request and provide the requested documentation.
  9. Be mindful of your body language. Don’t fidget, shift around, touch your face, hold yourself in aggressive postures, or act overly nervous.
  10. Never answer “off-the-record” questions or provide guesses or approximate answers. New call-to-action

3. Not Focusing on Upstream Quality

Medical device manufacturing is a complicated process filled with regulations and oversight every step of the way. While the FDA has limited scope with regards to punishing you for your supplier’s quality mistakes, problems upstream cause bigger problems downstream.

As you’re implementing your quality management system, make sure that you include ways to check and document your supply quality to maintain compliance with 21 CFR 820.50.

RELATED READING: How to Clear the 21 CFR 820.50 Hurdle in 7 Easy Steps

4. No Process for the Audit Itself

When the FDA shows up, you shouldn’t be scrambling nervously to figure out what to do. Plan ahead and have a process to follow during the audit.

Make sure that your plan includes:

  • A location where the inspectors can comfortably work.
  • Who is responsible for which pieces of information regarding your processes.
  • Which parties will be responsible for each piece of material the auditors could request.

5. Poor Complaint Handling

Many auditors will start by inspecting whether or not you have received complaints of potentially defective devices. The QS/GMP regulation stipulates that all complaints are required to be reviewed, evaluated, and documented by a formally designated individual or department. This unit is required to be staffed with individuals that have received proper training in response and investigation of complaints.

You are also required to have written procedures in place for how you process these complaints. Many manufacturers will store their complaints directly in the customer’s files. However, this is a red flag to auditors.

When your records are disjointed, it’s harder for you and the auditor to assess if you have recurring and similar complaints about a device. An auditor will want to know if you regularly perform an analysis of complaints or if you can easily produce documents that meet the definition of a complaint pursuant to 21 CFR 820.198.

6. Using Disjointed Software

Disorganization is another red flag to an auditor. When your systems are disjointed and spread across spreadsheets, paper records, and in multiple places, they understand that you have a tough time staying organized and identifying problems. They also immediately see how much time they are going to waste during the audit.

Like any employee, when they recognize a long and tedious day beginning, this does not put the auditor in an agreeable mood and sets the tone for your audit before it even begins.

You should consider investing in a quality management software (QMS) to help you get organized. Request a demo of Qualio and learn how closed-loop quality management can help you be audit-ready 24/7/365.

7. Lack of Internal Auditing

An FDA audit should not be the only audit that you experience. If you are regularly conducting internal audits that include items from FDA audits, you will be more prepared when they come knocking.

Your internal audits will do more than ensure your compliance with federal regulations — they will also prepare your team.

You can improve your quality and documentation with the right training, tools, and experience. Training your team is a different problem to tackle. You need to create an environment and culture based on quality and proper documentation and prep your team for conducting themselves accordingly in an audit.

Learn how to build the right culture and processes by downloading our free eBook: 7 Things You Can Do Now to Improve Quality in Medical Device Product Development. New call-to-action

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Published by Robert Fenton July 2, 2019
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