At QualityHub, we have experience in FDA auditing for several types of companies and situations. Here are three examples of auditing case studies to give you some background on that experience.

Warning Letter

Auditing Case Study

For a major medical device manufacturer under a warning letter, QualityHub provided over 20 before-and-after quality system audits of the client’s manufacturing sites in the U.S. and Europe. These audits allowed the company to gauge whether their quality system rebuild and remediation activities were successful. The project also involved a third visit to each of the sites to prepare them for FDA inspections.

Several Warning Letters

Auditing Case Study

QualityHub visited approximately 20 sites in the U.S., Mexico, Canada and Europe for a major medical device company under several warning letters. While most of the audits were against 21 CFR 820 (the medical device quality system regulation), some of the sites were also audited to the Drug GMP 21 CFR210/211 regulations.

Corporate Internal Audits

Auditing Case Study

QualityHub performed corporate internal audits for several of the more difficult sites for a major international medical device company. For these successful audits, QualityHub provided veteran auditors with experience handling complex and difficult situations. We continue to provide support to this and several other companies in order to assist in the execution of their complex internal audit programs.1.