21 CFR 820 QMSR & ISO 13485 CAPA
FDA Consulting CAPA Remediation
We will help you correct the deviations permanently to prevent recurrence through FDA consulting CAPA remediation. If you have received FDA Form-483 after an inspection or a Warning Letter from the FDA, you have come to the right place. Let us help you identify the root cause and implement effective corrective actions to prevent repeat violations.
What is CAPA?
CAPA refers to the Corrective and Preventive Action process defined and expected by the FDA and ISO 13485. It’s a vital part of quality systems for medical device, also pharmaceutical manufacturers.
What’s Corrective Action? Firstly, steps have been taken to eliminate the root cause of an existing OOS (out-of-specification) or nonconforming product or event. Secondly, preventive action is steps taken to eliminate the root cause of a potential nonconforming before it occurs. Thus, investigating the nonconforming issues, conducting root cause analysis, correcting the causes of the root cause, preventing recurrence, and documenting are the primary purposes of CAPA. It has to be risk- and science-based, timely, and well-documented. The most responsible person is expected to be involved throughout the FDA consulting CAPA remediation.
Should I be Worried?
Received FDA Form-483, Inspectional Observations, with about two to four items that appear to be nominal observations. Should I be worried? It depends. If the issues can be fixed within days or are minor observations, and you promised to fix them, it could be classified as a Voluntary Action Indicated (VAI).
However, if you see any reference to any kind of validation, for example, sterilization, aseptic media fill, process, packaging, cleanroom, purified water or WFI, or software, OOS that could result market removal or field correction, or anything observation that cannot be corrected immediately, your inspection could classified as OAI (Official Action Indicated). Also, even a single MDR citation can be significant because MDR is a standalone regulation. Therefore, a violation of the MDR may carry more weight than a few 820 minor citations.
In addition, if it’s a repeat violation from the previous inspection, even a minor one, you have the right to be concerned. Form-483 serves two primary purposes: 1. an official record for documenting deviations, and 2. initial notification of violative conditions. This is why the FDA calls a Warning Letter since they have already been notified in Form-483. If you have not received Form-483, the FDA may use an “Untitled Letter.” However, if you don’t correct the conditions mentioned in the Untitled Letter, the FDA may follow up with a WL.
What is OAI and Why FDA Consulting CAPA Remediation?
OAI refers to when the FDA classifies an inspection as Official Action Indicated. An OAI situation occurs when the FDA issues Warning Letters, seizures, injunctions, prosecutions, civil monetary penalties, or other enforcement actions.
There are instances when you may not have received a Form 483 but have had extensive discussions with FDA inspectors regarding specific issues such as PMA or 510(k) related, labels and labeling, advertisements, claims, etc. In these cases, you should anticipate hearing back from the FDA and may even be classified as Official Action Indicated (OAI). FDA investigators serve as the “ears and eyes” of the FDA. As such, they will not comment on PMA or 510(k) submissions, but verify the accuracy of the submissions.
Contact us immediately if you are unsure or concerned after an FDA inspection, so we can start FDA Consulting CAPA remediations immediately.
“The man who asks a question is a fool for a minute, the man who does not ask is a fool for life.” Confucius
Excutives Roles and Responsibilites
Senior executives in the pharmaceutical and medical device sectors should not wait to receive an FDA Form 483, which details Inspectional Observations, or a Warning Letter from the Food and Drug Administration (FDA) before taking action on Corrective and Preventive Action (CAPA) remediation.
You can prevent a routine quality assurance task from escalating into significant issues that may incur unnecessary costs and require specialized field experts. Focus on efficiency and practicality instead. This is the primary reason we strongly recommend doing a mock FDA inspection or gap analysis (or gap assessments) today! Do not delay any further or wait for FDA notification regarding the inspection. It may be too late to respond adequately when inspectors arrive at your premises or when you receive a call from the front receptionist that states, “The FDA is here.”
Subject Matter Expert (SME)
What could be worse? The situation can swiftly escalate from a straightforward corrective and preventive action (FDA Consulting CAPA Remediation) to a protracted and expensive undertaking if a jack of all trades is brought on board to address the FDA deficiencies outlined in the Form 483.
You must involve subject matter experts (SMEs) in their respective areas for every CAPA situation, not just one. There are many good FDA consultants or former FDA investigators out there. Also, there are many people with 30+ years of experience in the medical device or pharmaceutical industries out there. Because they have a higher education or more experience, it doesn’t mean they are suitable for the job, especially in CAPA remediation, unless, of course, they have specific expertise in CAPA. The ideal candidate for the job has extensive years of experience with the same procedures. This is where we come in. We have SMEs in every field, such as computer and software validations, sterilization and packaging integrity experts, process validation, aseptic media fill qualification, environmental monitoring, IVD, formulation, and testing laboratories (endotoxin, microbial, pyrogen, or bioburden, etc.).
Why We Are the Best Choice for FDA Consulting CAPA Remediation
We are a team of former FDA investigators, scientists, microbiologists, engineers, lawyers, chemists, reviewers, and compliance officers specializing in CAPA remediation. It is all we do: CAPA Remediation, mock FDA inspection, and Gap Analysis. Correct before they are too late or it becomes uncontrollable and costly. We can come in and start with a mock FDA inspection or gap assessments, a vital tool to assess the readiness for the FDA inspection. On top of that, your quality personnel will gain experience in handling real situations. Thus, it helps prepare people to cope in dire conditions with FDA inspectors.
Don’t let money be a deciding factor when choosing your consultants.
There are many FDA Consulting CAPA remediation consultants and agencies throughout the world. Some charges much less, especially if they don’t understand the magnitude of CAPA, or outrageously if they have to hire an expert to do the work. Either way, money should not dictate the use of FDA consultants. Due diligence involves reviewing their work and background. However, none other than a former FDA medical device specialist investigator can help you fix it. It would be better if they had experience in both medical device investigator and compliance officer jobs. For instance, the investigator will understand 483 issues better than anyone, and the Compliance Officer will understand the Warning Letter. One of our senior consultants has been working for the FDA as a chemist, medical device investigator, and Compliance Officer. He issues numerous 483s and Warning Letters to medical device manufacturers.
Avoid an “Official Action Indicated” at all costs!
We can assist you with remediation following a perilous FDA inspection, but our goal is to avoid such a situation. While we cannot guarantee a “No Action Indicated” (NAI) status of an FDA inspection, we can together help prevent “Official Action Indicated” (OAI) if you engage us early in the process. Test your FDA inspection today by allowing us to do gap analysis in your quality and manufacturing operations. Remember, any repeated violations, regardless of how severe or significant they are, could result in an OAI. Don’t repeat the same observations through FDA Consulting CAPA Remediations.
Partner with us for Long-Term Success
FDA Consulting CAPA Remediation is what most medical device manufacturers need, regardless of whether you have received an FDA inspection or not, or received Form FDA-483, Inspectional Observations, listing noncompliance, Out-of-Specification (OOS), or other quality departures.Let’s conduct a mock FDA inspection or gap analysis to evaluate your current situation. You can confidently prepare for the upcoming FDA inspections.
If you have not experienced it before, receiving a Warning Letter can significantly impact your company, products, and personnel. In addition, stocks, stakeholders, and other interested parties may be affected by it. Engage us today!
CAPA is a never-ending cycle.
Our team comprises former Senior Investigators from the FDA, experts in their respective fields, Microbiologists, and Compliance Officers. For decades, we have dedicated ourselves exclusively to the areas of Corrective and Preventive Actions (CAPA) and Gap Analysis. This specialized focus continues to define our current endeavors.
What are the common CAPA (Corrective and Preventive Action) remediations?
The common CAPA remediation for medical device and pharmaceutical manufacturers typically involves updating, requalification, revalidation, retraining, or revising Standard Operating Procedures (SOPs). This is followed closely by monitoring implementation.
Here’s a sample of the most common CAPA remediation actions:
- SOP Revisions. Updating or rewriting procedures to ensure compliance with the FDA requirements. Often required when OOS (out-of-specification) is linked to outdated or unclear procedures.
- Validation and Revalidation. A critical Corrective and Preventive Action (CAPA) remediation is necessary when the deviations are too broad to address effectively. This is where FDA Consulting CAPA Remediation comes in. Process validation for automated manufacturing processes.
- Employee Retraining. Conducting focused training sessions on the revised procedures or regulations. Ensures that employees understand and implement compliant processes to prevent recurrence.
- Root Cause Analysis (RCA). Using more rigorous or structured RCA methods. Ensures that the actual cause is identified and addressed.
- Process Changes or Redesign. Modifying processes, workflows, or equipment to eliminate risks. Revisit Design Control (DC)
- Improved Documentation and Record Keeping. Revise documentation processes to ensure traceability and audit-readiness. Includes better design history files (DHFs) and device master records (DMRs)
- Conduct Internal Quality Audits and Mock FDA Inspections. Increasing the frequency or scope of internal audits to catch issues earlier.
- Management Review and Oversight. More active or structured involvement of senior management in quality issues. Implement quality metrics dashboards, more frequent quality review meetings, or add QA checkpoints.
- Vendor Qualification / Supply Chain Controls. Required when raw material variability, supplier compliance, or traceability issues are the root cause.
Pharmaceutical Manufacturers
For pharmaceutical manufacturers, the most common CAPA remediation actions are similar in structure to those in medical devices but tend to focus more on Good Manufacturing Practice (GMP) compliance (21 CFR 211), data integrity, and process control.
In addition, you will find that the above FDA Consulting CAPA remediation are usually identified during other agencies, such as ISO 13485 certification, MHRA, or EMA inspections.
However, the motive for adopting strict quality control should be a quality culture. FDA Consulting CAPA Remediations can help!
Here are examples of the top 20 most common observations:
Based on FDA inspection data and industry analyses, here are the top 20 most common FDA Form 483 observations related to Corrective and Preventive Actions (CAPA) under 21 CFR Part 820 for medical device manufacturers:
Top CAPA-Related FDA 483 Observations for Medical Device Manufacturers
- Inadequate or Missing CAPA Procedures. Failure to establish and maintain procedures for implementing corrective and preventive actions.
- Lack of Documentation for CAPA Activities. CAPA activities and results are not adequately documented.
- Failure to Analyze Quality Data. Not analyzing sources of quality data to identify existing and potential causes of nonconforming products or other quality problems.
- Failure to adequately investigate the cause of nonconformities relating to product, processes, and the quality system.
- Not verifying or validating the effectiveness of corrective and preventive actions to ensure they do not adversely affect the finished device.
- Failure to implement CAPA in a timely manner. Delays in implementing corrective and preventive actions after identifying quality problems.
- Inadequate Management Review of CAPA. Management is not ensuring that information related to quality problems is disseminated to those directly responsible for assuring the quality of the product.
- Personnel is not adequately trained to perform their assigned responsibilities related to CAPA.
- Not identifying the actions needed to correct and prevent recurrence of nonconforming product and other quality problems.
- Failure to implement and record changes in methods and procedures needed to correct and prevent identified quality problems.
- Corrective and preventive actions are not integrated into the quality system processes.
- Not monitoring the results of corrective and preventive actions to ensure effectiveness.
- Failure to maintain records of investigations and actions taken.
- Inadequate Analysis of Trends. Not analyzing quality data to identify and act upon trends that may indicate quality problems.
- CAPA Not Addressing All Affected Products. Corrective and preventive actions were not extended to all products and processes potentially affected by the identified quality problem.