Most Common Reasons For FDA Form 483 Observations And Warning Letters In Medical Device Environments

By Brian Curran

Regulatory inspections conducted by the U.S. Food and Drug Administration (FDA) are commonly followed by a list of observations noted during an audit. Issues that are considered objectionable conditions or compliance violations by FDA inspectors are itemized in a Form 483 or a warning letter. These notices follow a standard process, beginning with an enumeration of specific findings, follow-up instructions, a deadline for completing the follow-up instructions, and potential consequences for failing to make the necessary corrections. Upon receiving either type of notification, the company is obligated to acknowledge receipt of the document and craft a detailed course of action for correcting the infractions.

Regulatory violations that result in a Form 483 or warning letter commonly involve one or all of the following deviations:

• Not having quality control procedures in a regulated area that conform to FDA regulations.
• Having procedures that conform to FDA regulations, but not following them.
• Having procedures that conform to FDA regulations and following them, but not having adequate documentation to provide evidence of compliance.

In this article we help you understand the FDA’s updated approach to medical device regulation and provide information about inspection observations so you identify and mitigate compliance issues more easily.