The most effective tool for FDA compliance status
Mock FDA Inspection by Ex-FDA Investigators
Consider conducting a mock FDA inspection with your staff to prevent a catastrophic event. This proactive measure can help you identify gaps and close them before they become 483 deficiencies during an actual FDA inspection. Correcting 483 citations is costly and can result in negative publicity.
“An ounce of prevention is worth a pound of cure.”
“To Err is Human.” But, Why We Have No Room To Err
That’s because we are in a life-saving business. The margin of error is zero. In other words, we are committed to the health and well-being of our patients. As such, we cannot afford any human errors. It is crucial that we ensure no non-conforming quality products enter the distribution channel.
How to Prepare for an FDA Inspection
How to prepare for an FDA inspection is the most common question asked by many drug and medical device companies. Fortunately, one of the most effective tools is a mock FDA inspection. That’s how renowned medical device and drug manufacturers maintain the highest possible compliance with the FDA and other global regulators.
Due to the advancement of technologies or artificial intelligence (AI), Process Validation is crusial and where many manufacturers struggle with. Our consultant is a subject-matter expert (SME) in this area and can help you prepare for FDA inspection.
Before an FDA inspector arrives, we can review the company’s Quality System Manual, Quality Management System, GMP, QSR, CAPA, and manufacturing operations. Additionally, we can practice, strategise, organise, and train your staff to help them understand what actual FDA inspections entail.
Only highly qualified auditors perform mock FDA inspections.
For example, one of our principal FDA consultants has many years of unmatched experience inspecting medical devices and drug manufacturers. Furthermore, he has received the following certifications from the US FDA:
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- Performance Auditor Certification in 2003
- Investigator Certification in 1997
We will utilise our knowledge and experience to prepare you and your team for an FDA inspection of your manufacturing facilities. By choosing our mock FDA inspections, you can close any gaps in your quality system.
Mimicking FDA Inspection
Our FDA consultant will follow the latest FDA guidelines, the FDA’s Compliance Program Manual, and the Investigations Operations Manual (IOM) when conducting an audit. Please understand that we don’t promise that you will avoid receiving Form-483 or any observations. In fact, no one can make such vogus claims. However, we can help you identify any areas for improvement. As such, let us help your staff prepare for an FDA audit.
Practice, practice, and be ready when the FDA knocks on your door. Remember, fixing observations is far more resourceful than preventing one.
Align with US Food and Drug Administration Laws
Whether you seek expert help inspecting your company’s quality policies or reviewing your various manufacturing practices, we are here. RAQA FDA Consultants are eager to help you become aligned with FDA regulations such as CGMP, QSM, and QSR. As such, we bring an experienced team motivated and keen to help manufacturers by sharing our expertise.
By examining your manufacturing operations’ quality policies and procedures, we can help your company achieve better compliance and provide insightful advice.
Mock FDA Inspection to Avoid a Warning Letter
Official Action Indicated (OAI) classification indicates a manufacturer is out of compliance. It’s a negative image and publicity. RAQA Regulatory Firm is here to help you as a subject matter expert (SME).
If you are a senior executive, your primary duty is to avoid receiving a warning letter (WL) from the FDA at all costs. Fixing an FDA WL will cost you time, money, and effort and may have a negative impact on your company, its products, and the morale of your people.
If you have yet to comprehend the magnitude of a Warning Letter, trust us on this. So, choose our confidential mock FDA inspection by ex-FDA investigators. Again, we don’t claim the result of our mock inspection will not result in an OAI. It’s up to you to adhere to the laws and regulations and to bring your quality to compliance.
OAI
Avoid Official Action Indicated (OAI) Classification at All Costs!
Why conduct a mock FDA inspection?
Unfortunately, the media, politics, and stakeholders are looking for an easy mark to blame whenever possible. Unfortunately, drug or medical device manufacturers are easy prey. Practising an audit can help you avoid whatever “blame game” is playing. Therefore, if you are one of those “designated high-risk” manufacturers, complying with FDA laws is a lifeline.
Contact us today to schedule a mock FDA inspection by our ex-FDA investigator. We are just a click away. Please don’t wait until you receive notification from the FDA. Some corrective actions or validations may take several months if not years.