FDA Inspection Assistance by an ex-FDA Investigator
We Offer FDA Inspection Assistance
ALP Sourcing assists during your FDA inspections for medical device, food, dietary supplement, and pharmaceutical drug manufacturers. Our FDA Consultant provides FDA Inspection Assistance services during your scheduled FDA Inspections. No matter how prepared you are for an upcoming FDA inspection, you will always feel unsure and insecure that you could do more. Sometimes you do not have anyone to consult in your organization or discuss with during the FDA inspection. That is where ALP Sourcing comes in. In addition to mock FDA audits, we can be there during your upcoming FDA inspection to consult with about any issues that may arise with the FDA inspector. Remember, we have been there before, so we are in a good position to consult with you during the FDA inspection.
Contact Us Immediately
When you receive notice of a preannounced inspection from your FDA office, contact us as soon as possible. We are not always available, but we will try to make an arrangement with you as best as we can. If we have performed mock FDA inspections of your facility before, then you will have priority in scheduling as FDA Inspection Assistance.
Let ALP Sourcing be there during your next preannounced FDA inspection as an advisor who can offer a second opinion. Having us, there will support you not only mentally but technically as well. If at all possible, then we would like to arrive at your facility a day before FDA inspection in order to strategize and make the stressful event easier and more efficient. Turn the event into an excellent opportunity to experience and learn on behalf of everyone in your organization. Your organization’s employees will be more appreciative of your job function. Furthermore, it will help understand the importance of complying with current good manufacturing practices (CGMPs).
Keep in mind that it is not a good practice to make quick fixes and corrections immediately before the FDA inspection. Problems should have been identified during mock FDA audits and corrected well before the FDA inspector’s arrival. For that reason, we recommend scheduling mock FDA inspections with us as soon as possible. Don’t wait. The sooner you identify and fix problems with non-compliance, the better prepared you will be for your next preannounced FDA inspection.
Talk to us immediately for FDA Inspection Assistance.
The Technical FDA Inspection Assistance
Don’t worry if you are unable to get your company fully prepared for the U.S. FDA inspection. We can be there to support your staff during your upcoming FDA inspections. Also, we would like to be there two or three days before the actual inspection to strategize. It will help your staff handle more effectively, not to mention potentially avoiding catastrophe by unprepared approach.
Many pharmaceutical and medical device quality personnel are experiencing difficult positions during the inspection. That’s where you should look getting help from a team of professionals like us for FDA inspection assistance.
Our FDA consultants have been known for providing good moral guidance for US FDA audits. Besides, we have made it possible for manufacturers to achieve their desired results by taking insightful opinions and consultation.
By working with us and choosing our ex FDA inspector to review your quality manual and provide insightful recommendations, you will make the best decision. Also, we are a dedicated team of experts who have spent many years servicing manufacturers with our consultancy.
We have got the experience and knowledge to assist manufacturers during the FDA audits.
In fact, we review key elements and areas that require more attention. By conducting these simulations, you can draw a conclusion which you can focus upon to bring your quality system into compliance with the FDA laws and regulations.
Our 30 years of unrivaled experience in providing manufacturers with FDA inspection assistance position us on the list. Not only medical device and drug manufacturers have trusted us, but recommend us for our commitment and dedication towards helping manufacturers achieve maximum compliance with the U.S. FDA laws and regulations.
Our FDA consultants are widely recognized for helping those manufacturers who want to be prepared for US FDA audits. By opting for our FDA inspection assistance and consultancy, you will step in the right direction.
Ex FDA CSO for FDA Inspection Assistance
From those manufacturers that are about to start their operations to those who have been in the industry for several years, maintaining strict compliance to the US FDA laws and regulations appear to be the most important element.
If you are unsure about your manufacturer’s current compliance regarding U.S. FDA standards, choose our FDA consultants.
We are here to provide you with a highly experienced and certified ex FDA CSO who can help your company adheres to and complies with the FDA requirements. Our FDA consultant has continued to serve many biotechnology manufacturers with our exceptional expert services for many years.
By earning such an unmatched experience and industry exposure, ALP Sourcing has been able to keep our clients satisfied with FDA inspection assistance.
There are reasons for which you should look no further than ALP Sourcing.
- We are the team of experts you have been looking for.
- Our ex FDA CSO will conduct critical tests and simulations to help your company keep up with the required FDA laws and regulations.
- ALP Sourcing has spent decades assisting manufacturers with FDA inspection assistance.
You can find several similar service providers within the industry, but before you decide, consult with us. Please don’t wait. Reach out to us now before your manufacturing goes FDA inspection.
FDA Inspection Assistance by a Former FDA District CSO
Whether it is about training your employees or rehearsing the FDA inspection, you need our FDA consultant to assess these key elements better.
It’s not a big deal if you have never had an experience of the actual FDA inspection. You can practice with our former FDA Consumer Safety Officer (CSO). In other words, our former FDA investigator can provide you FDA inspection assistance.
By opting’s ALP Sourcing’s team of former FDA CSO, you will be able to integrate the most comprehensive inspection to spot improvement areas. Our former FDA CSO has the experience and expertise to review your quality system. The sooner you contact, the more time to prepare for your future FDA inspections.