SHAPING YOUR QUALITY

FDA Gap Assessment Analysis

Medical device and pharmaceutical drug manufacturers should schedule a gap assessment analysis as soon as possible to ensure that the quality unit aligns with the latest 21 CFR 210, 211, 820, and ISO 13485. Title 21 of the CFR is reserved for the United States Food and Drug Administration (FDA) to enforce the medical device and pharmaceutical manufacturers.

Quality Management System Regulation (QMSR)

21 CFR §820.22 Quality Audit

Establishing and conducting internal quality audits “by individuals who do not have direct responsibility for the matters being audited” is a requirement. As a medical device manufacturer, it’s your duty to conduct an FDA gap assessment analysis and comply with relevant laws and regulations, specifically 21 CFR 820, 211, and 803.

FDA Form-483, Inspectional Observations

An FDA Form-483 is issued to firm management at the end of an inspection when investigators observe conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act and other regulations. Additionally, the 483 does not represent the final Agency assessment of whether any condition violates the FD&C Act or relevant regulations.

“They are inspectional observations, and do not represent a final Agency determination regarding your compliance.” Note from FDA Form-483, Inspectional Observations.

FDA Warning Letter or Untitled Letter

Furthermore, if you received a Warning Letter from the FDA, usually the last paragraph states in part:

“You should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.”

As such, periodic FDA gap assessment analysis is the best way to comply with the above Warning Letter statement.

“The Calm Before The Storm”

Never Received 483 or a Warning Letter? Take advantage of the opportunity and continue to improve by addressing any remaining gaps.

If your previous FDA inspection resulted in an NAI (No Action Indicated) and no Form 483 was issued, it doesn’t mean you are out of the woods. Usually, defending your championship is harder. As such, it’s even more critical to conduct gap assessment analysis as soon as possible to uncover unidentified deficiencies or minimize the chance of receiving an FDA Warning Letter.

Bring It On Ready!

Schedule to conduct a period or annual FDA gap assessment analysis with us for many benefits:

• • Meet the 21 CFR 820 Quality Management System Regulation (QMSR)
  • Align with the 21 CFR 210 & 211 Current Good Manufacturing Practices (CGMP)
  • Review 21 CFR 803, Medical Device Reporting provision
  • Ensure the highest level of quality, and
  • Be ready for FDA inspection

Who is the FDA Gap Assessment Analysis Intended for?

For the past 20 years, we have conducted gap analyses for medical device and pharmaceutical manufacturers. From management control to handling consumer complaints and automatic warehouse distribution to raw material handling, we have the experience and knowledge to close any gaps.

Many consultants offer similar services, and we understand the challenging decision you face in selecting the most qualified auditor for your products. Former FDA medical device investigators with at least ten years of experience and thorough knowledge of your process will be the most suitable candidates for this enormous and vital task.

For example, if you are an in vitro diagnostics manufacturer, you want to find someone who has inspected one of the largest and most complex in vitro diagnostic manufacturers. In fact, our FDA consultants have experience inspecting one of the largest in vitro diagnostic manufacturers in the world as FDA medical device investigators.

Your Company Deserves the Services of ex-FDA Investigators

Unlike other FDA consulting firms, we only allow ex-FDA investigators experienced with various types of medical devices to perform an FDA gap assessment analysis. We are not simply conducting an audit; we are also providing you with the best recommendations for corrective and preventive actions (CAPA) based on our extensive experience with similar products, including those of your competitors.

We Travel the World for an FDA Gap Assessment Analysis

Hundreds of years of combined experience from our FDA consultants have allowed them to travel worldwide and witness various manufacturing operations. Don’t settle for second best. Money should not be a deciding factor. Instead, qualifications and experience are crucial factors to consider when selecting an auditor. We have previously traveled to various countries, including Ireland, France, Finland, Norway, the UK, Switzerland, Germany, Italy, India, Thailand, China, Japan, South Korea, Denmark, Canada, and the Netherlands. We have experience in various manufacturing operations, including injection molding, software development, electronics, IVD, printing, catheters, CNC milling, ceramic implants, sterile products, and WFI.

Why not hire experts to do it?

If your in-house auditor is not an expert or a former FDA medical device investigator, why not consider hiring one?

Our team is comprised of:

• • Former FDA Investigators in medical device and pharmaceutical
  • Former FDA field Compliance Officers who have issued numerous FDA Warning Letters
  • Experienced in gap assessment analysis

Why not take advantage of the opportunity by engaging an expert to conduct an internal quality audit?

According to the new 21 CFR §820.22 Quality Audit of Quality Management System Regulations (QMSR), you have a system established for conducting internal quality audits. For the same price, you can hire experts like us. In fact, you can outsource all your internal quality audits to us, allowing our former FDA investigator, who chooses a different expert every year, to provide fresh perspectives and insights. It will not only meet the requirements but also enhance the quality of your products and address any gaps in the quality system. Therefore, your annual quality audits have evolved from a mere formality to a vital component of quality culture within the QMSR. Additionally, it complies with ISO 13485, UK MHRA, European EMA, TGA, Korean FDA, Canadian MDD, and Japanese PMDA regulatory requirements.

How do you select an FDA Gap Assessment Analysis auditor?

Choosing an FDA Consultant with at least 10 years of experience as an investigator is significantly more advantageous, particularly one specializing in medical devices or pharmaceutical manufacturing.

Also, understanding your manufacturing operations and industry is crucial. Therefore, having at least 10 years of experience in FDA gap assessment analysis as an auditor in the manufacturing sector is preferred. One thing is sure: you should avoid anyone without FDA experience for gap assessment analysis. Additionally, even if a person has FDA experience, if they have not worked as a medical device investigator, they are not suitable to serve as auditors.

FDA Gap Assessment Analysis versus Mock FDA Inspection.

Many medical device and pharmaceutical manufacturers often grapple with a pivotal question: Should they conduct a gap analysis or a mock inspection? This query typically arises among professionals responsible for quality assurance within their organizations. A mock inspection simulates a regulatory review process, providing a selective assessment of compliance with industry regulations and internal protocols. Both approaches have their unique advantages and can offer valuable insights; however, the choice between them should be guided by the specific needs, regulatory requirements, and overall objectives of the organization. On the other hand, a gap assessment analysis serves as a tool to identify discrepancies between current practices or outcomes and the desired standards, enabling companies to pinpoint areas in need of improvement.

Our FDA Consulting recommends doing both.

Both tools offer tremendous value in enhancing your operational effectiveness. It is advisable to commence with a thorough gap analysis, a critical step in evaluating your current situation and identifying any discrepancies that require attention. Allow a timeframe of six months to a year for your quality unit to comprehensively examine and resolve any issues, as well as to implement necessary Corrective and Preventive Action (CAPA) remediation based on the findings of the gap analysis. Following this rigorous process, it is crucial to conduct a mock FDA inspection, which will provide invaluable insights and prepare your team for future regulatory scrutiny.

How do we conduct an FDA gap assessment analysis?

To perform a gap analysis for the QMSR, we will first identify any nonconformities or compliance gaps by understanding the regulations. Here is an outline of routine audits; it may take about two weeks to cover all surfaces. 21 CFR Part 820 Steps:

1. Understand the Requirements of 21 CFR Part 820 Quality Management System Requirements

Review regulation (Subparts A–O):

• Management responsibility
• Design controls
• Document and record control
• Production and process controls
• Corrective and preventive actions (CAPA)
• Complaint handling

Internal audits

2. Assemble a Cross-Functional FDA Gap Assessment Analysis Team

Include representatives from:

• Quality Assurance (QA)
• Regulatory Affairs
• Engineering
• Manufacturing
• Document Control

3. Gather Existing Quality System Documentation

• Quality Manual
• Standard Operating Procedures (SOPs)
• Work Instructions
• Forms and records
• Training records
• Internal audit reports

4. Develop or Use a Checklist

• Use a clause-by-clause checklist based on 21 CFR 820 QMSR. Optionally include ISO 13485 clauses.

5. Perform an FDA Gap Assessment Analysis

Evaluate each section against your current practices and determine:

• Fully met
• Partially met
• Not met

Collect objective evidence.

6. Document the Gaps

Create a structured report including:

• Regulation clause
• Current status
• Gap description
• Risk level (low/medium/high)
• Recommended corrective action

7. Prioritize Gaps Based on Risk

• Focus on high-risk or compliance-critical areas (e.g., design control, CAPA).

8. Develop a Remediation Plan

• Assign responsibilities, define actions, set deadlines, and ensure management oversight.

9. Implement and Track Corrections

• Update procedures, train staff, and monitor progress with audits or reviews.

10. Verify and Close Gaps

• Conduct follow-up audits to ensure corrective actions are effective.

Optional: If applicable, map 21 CFR 820 clauses to ISO 13485:2016 for global compliance.

Even though we have never had issues with the FDA, why should we consider an FDA gap assessment analysis?

Every manufacturer regulated by the FDA is part of this critical framework. Inclusion in this process is essential for achieving compliance with industry standards and is a crucial element of proactively maintaining your quality management system. By consistently evaluating and refining your practices, you not only meet regulatory requirements but also significantly improve product safety and effectiveness. Emphasizing this commitment demonstrates your dedication to excellence in quality assurance.

Again, to answer the above question, yes, you absolutely should consider an FDA gap assessment analysis for 21 CFR Part 820, even if you’ve never had issues with the FDA. Here’s why:

1. FDA Inspections Are Often Unannounced

• The FDA can inspect at any time, especially for Class II and III devices.
• A gap assessment ensures you’re not caught off guard and that your systems are inspection-ready.

2. Compliance ≠ No Findings

• Not being cited doesn’t mean your system is fully compliant.
• “No news” isn’t always “good news” — you might have undetected risks or outdated procedures.

3. Regulations and Expectations Evolve

• 21 CFR Part 820 is aligned with ISO 13485:2016 updates.
• The FDA is harmonizing with international standards, which may affect inspection focus.

4. Internal Risk Mitigation

• An FDA gap assessment analysis can catch weaknesses before they become regulatory violations (e.g., in CAPA, design controls, or complaint handling).
• Prevents product recalls, warning letters, or consent decrees.

5. Enhances Quality Culture

• Shows proactive commitment to quality and patient safety.
• Boosts internal accountability and cross-functional awareness of regulatory obligations.

6. Strengthens Documentation and Audit Trails

• Helps ensure your document control, training records, validation reports, etc., are complete and current.
• This is often where companies are cited, even those with good products.

7. Adds Value During M&A, Partnerships, and Certifications

• A clean, well-documented quality system is a competitive advantage.
• Especially critical if you’re pursuing ISO 13485 certification, MDSAP, or global expansion.

“No previous issues” is not a compliance strategy — it’s a temporary state.

An FDA gap assessment analysis is how you make sure it stays that way.