The FDA requires regularly schedules internal audits. An adjunct to this schedule is a third party inspection. The outside audit puts new and objective eyes on your system. Since your Quality System is a living document and may undergo changes purposely or sometimes inadvertently. Subtle changes or more obvious ones may occur without recognition and documented change to your SOPs. From our experience, a good many of the 483s occur when the SOPS and the actual procedure do not match. Our objective is to identify those non-conformances that may occur by omission or commission and assist your company in correcting any anomalies. Pre-Audit Preparation for FDA Inspections A pre-FDA audit can assist your company in preparing for your audit, identify any trouble spots and resolve them before the FDA audit rather than responding to FDA 483 observations after the audit. Can I have a consultant during an audit? Yes. Most companies do not realize that they may have a third party representative for their company during an FDA inspection, as an observer and also to assist in the response if any 483 Observation should occur. Smith Associates has represented companies as an on-site consultant during FDA inspections internationally and in the United States. Our resume includes Class III FDA audits for device PMAs, in-vitro diagnostic PMAs and Class I and II FDA audits. The FDA just called for an inspection next week, but my Quality System is not complete…now what? And what a feeling that is to be ill prepared for a surprise inspection. We can help you fill in your Quality System gaps or provide an entire QS with our Implementation-Ready Quality System FDA has scheduled an inspection…am I prepared? A pre-FDA audit can assist you in preparing for your audit, identify any trouble spots and resolve them before the FDA audit rather than responding to FDA 483 observations after the audit. Can I have an outside representative as my management representative during an audit? Yes. Most companies do not realize that they may have a third party representative for their company during an FDA inspection. Smith Associates has represented companies around the globe from Class III breast implants and in vitro diagnostic companies to Class I GMP-required manufacturers. ABOUT US Since 1994, under the direction of E J Smith, President, Smith Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, biologics and blood. This includes the most common route to clearance in the United States, the 510(k) submission (PMN), and also Pre Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510(k)s. QUICK LINKS Home Regulatory Services Quality System Human Factor Studies Our Projects Our Clients Contact Us COMPANY INFO Smith Associates P.O. Box 4341 Crofton, MD 21114 United States Local: (410) 451-0639 Fax: (410) 793-0448 Toll Free: (888) 729-9674 Copyright 2021 GLOCOM | All Rights Reserved | Powered by NWOL | English