The FDA is allowed to visit your company to perform an inspection. In the course of the visit they may bring some issue to your attention in the form of an observation (aka a 483). This article reviews what a 483 looks like, some of the more common issues flagged in medical device companies, and how to respond.
We invite you to download our paper on the topic of 483 Observations.
As 63% of companies plan to increase AI spending this year, there is a large focus on the ROI of AI tools. Ensuring you get the most out of your investment is vital to business success, especially in the service industry. This eBook explores how teams can integrate AI...
Compliance is not always about having the right documentation. In regulated industries, compliance is about proving that requirements are defined, changes are controlled, risks are addressed, tests are completed, and approvals are captured in a traceable, audit-ready...
Ginna Khang is an Applications Engineer focused on research and development (R&D). She started at SPK and Associates in 2022 as an intern while she attended UC Santa Cruz. After graduating in 2024, she was brought on full-time. Here is more about Ginna in her...
Hello everybody, and welcome back to another SPK and Associates vlog. My name is Michael Roberts. I'm the Vice President of Sales and Marketing here at SPK. Today we're talking about how industrial manufacturers are accelerating their time to market up to 15% by using...