Vendor Audits by ex-FDA Investigator

Vendor Audits

One of the most important aspects of the quality systems of a medical device or pharmaceutical drug manufacturer is monitoring the components or raw materials you receive from your vendors. ALP Sourcing mock FDA inspections also include vendor audits in compliance with 21 CFR 820.50(a)(1) Quality System Regulation. For critical component or raw material suppliers, you want to have absolute assurance that your vendors are in compliance with the FDA requirements. You do not want to be in a difficult position because your vendors are supplying you with non-compliant components. We will conduct vendor audits for you and make sure that they meet your specifications, including quality system requirements.

We will follow your standard operating procedures (SOP) for vendor audits, applying what we have learned during our 30 years of experience conducting FDA audits. Remember you are ultimately responsible for all components and raw materials that go to your final products. Let us confirm their compliance with the FDA requirements as well as your own specific requirements.

Annual Vendor Audits

Are you worried about your suppliers if they are not fully complying with the FDA regulations? Do you have certain doubts that your vendor policy does not match with the FDA laws and regulations? Then you should consult with us. We can guide and help you and perform annual vendor audits. 

It is indeed an alarming situation if you do not know about the FDA guidelines and regulations. ALPS FDA Consulting has continued to serve our customers for more than 15 years.

If you are one of those executives worried about the upcoming FDA inspections, you should immediately reach out to usALPS Team will critically determine and ensure that your employees are ready with the FDA regulations by conducting mock FDA inspections. In addition, we have developed a unique audits approach that follows the latest FDA guidelines.