White Paper

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

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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.

Medical device quality system regulations are documented in 21 CFR Part 820.1 Overall, the regulations are driven by the agency’s commitment to ensure timely patient access to high-quality, safe, and effective medical products. In support of this objective, the FDA continues to make adjustments and updates within its organization in order to keep pace with an evolving industry.

In 2019, the Center for Devices and Radiological Health (CDRH) underwent a reorganization. Rather than having different staff oversee devices at certain stages, the staff specializes in particular products and work in teams to follow devices throughout their entire life cycle. This transformation is a transition to a more holistic, team-based approach to premarket review, postmarket surveillance, and compliance that strengthens its focus on safety and
effectiveness throughout the entire life cycle of medical devices.2

By understanding the FDA’s updated approach to medical device regulation and the information provided in this document about inspection observations, medical device companies can more easily identify and mitigate compliance issues.

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