FDA Compliance

The expectation of a quality unit is high for most medical device and pharmaceutical manufacturers. However, some senior management and executive take them for granted, expecting them to do their job with little support or training. In fact, the quality unit of a manufacturer is not a front driver of a company’s profit. Most often, the success credit of a company goes to the business side with little recognition of the quality staff.

The only time the quality unit is in the spotlight is when they receive the 483 after the FDA inspection, or better yet, if they receive a Warning Letter from the FDA. The quality unit takes the fall.

The Most Common Deficiency

The fact is that when it comes to FDA compliance, one of the most common deficiencies noted by FDA investigators during the on-site, routine inspection is a quality unit failure, which results in official actions such as a Warning Letter. As an Investigator and Compliance Officer with the field FDA office, Andrew issued many 483s and warning letters, citing:

“Failure to establish and follow written procedures applicable to the responsibilities of the quality control unit [21 CFR 211.22(d)].”

Among all the roles in a manufacturing company, the quality and compliance department faces the most stress. The high stakes of FDA compliance and the potential consequences of non-compliance make their job particularly challenging. Even more overtaxing of the quality unit, since most likely, the company and its investors depend on them.

Let’s Partner with Our FDA Compliance Expert

We have spent the majority of our career time dealing with FDA compliance and CAPA, and we are in the best position to help you and your quality team with FDA compliance.

It’s natural for your quality team to strive to improve their confidence in their roles. This is where we come in. We will work closely with your quality team to ensure compliance. Also, they are well-prepared for the next FDA inspection or to correct any past deficiencies.

How we can help your quality and compliance units:

1. 1. Train, practice, and be ready for FDA inspection by mocking
   2. Assist with FDA Form-483, Inspectional Observations, response
   3. Assist with the FDA Warning Letter response
   4. Consumer complaint handling and investigation
   5. Assist in handling non-conformance issues
   6. Investigating any unexplained discrepancies and other CAPA issues

A Message for Senior Executives

The success of your company depends on your people. Each employee has their part to achieve. Each department is an integral part of the companywide success. Your business and marketing team will most likely have plenty of support and training. Unequivocally, your quality unit must have your back. We are here for you. Let us be part of your FDA compliance contract employee.