Most Common FDA 483 Observations

by Brittany Wells

Most Common FDA 483 Observations

If your company is registered with the FDA, that facility will be inspected by the FDA to ensure everything is up to their standards. The FDA regulates food, medicines, vaccines, medical devices, cosmetics, and tobacco products. FDA Inspections are a critical part of the regulation process because they provide the FDA with information about how well regulated these industries are. During an inspection, federal inspectors will examine facilities and records to see if regulatory requirements have been met or if problems need to be corrected before continuing production or distribution. When issues arise, an FDA 483 observation is delivered to the company in question. “An FDA 483 observation, or “inspectional observation,” is a notice sent by the FDA to highlight any potential regulatory violations found during a routine inspection. This can relate to the company’s facility, equipment, processes, controls, products, employee practices, or records.”

Addressing a 483 can be expensive depending on what needs to be adjusted, reworked, or created from scratch. A company could require training, redesign, process implementation, and other measures. In this case, being proactive is a much better approach than being reactive.

Let’s look at the most common causes of a 483 observation:

  • Procedures not fully followed
  • Poor investigations of discrepancies or failures
  • Absence of written procedures
  • Data integrity issues
  • Cleaning, sanitizing, and maintenance
  • Environmental monitoring

How can you address these issues?

  1. Regular preventative mock audits to understand where the organization needs to focus.
  2. Follow CAPA (corrective and preventative action) plans. This process follows a mock or real inspection to address the root cause any non-conformities or other undesirable situations.
  3. Maintain up-to-date and accurate SOPs (Standard Operating Procedures). SOPs “aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.”
  4. Keep digital and physical records protected and backed up accordingly.
  5. “Conduct proper investigation for each and every incidence out of specification, out of trend, event deviation, or failure that happened in the manufacturing facility and in quality control lab. Each failed batch or test much be thoroughly investigated to the root cause even if/when the batch is not released for distribution.”
  6. Maintain proper cleaning, sanitation, and maintenance of all facilities and equipment.
  7. Perform environmental monitoring as appropriate for your industry.

Click on this link to learn more about how Compliance Insight can help you with your 483!