According to the FDA document, Investigations Operations Manual (IOM),“The FORM FDA 483 INSPECTIONAL OBSERVATIONS is intended for use in notifying the inspected establishment’s top management in writing of significant objectionable conditions, relating to products and/or processes, or other violations of the FD&C Act and related Acts which were observed during the inspection.” This statement and other background can be found in section 5.2.3 Reports of Observations of the IOM. The U.S. Food and Drug Administration (FDA) goes on to point out that these reports of objectionable conditions are made based on the judgment of the inspector. As with many government inspections, the inspector has discretion in his interpretation of what is “significant” and what is minor.  Nevertheless, the issuance of “written inspectional observations” is required by law.

Perhaps, the day comes around when your firm receives a 483 and you desire to cooperate with the FDA in addressing the objectionable conditions listed. One thing that you should be clear about is that this is not a ‘warning letter’; it is an offer to help you resolve issues and improve your quality system. The FDA may or may not issue a warning letter next if you have not addressed the conditions of the 483 to its satisfaction. Receiving a 483 does not necessarily mean you are out of compliance.

In responding to a 483, your objectives should include these three things; establish credibility, demonstrate acknowledgement and understanding of the observations and the associated requirements and show commitment to corrective actions. Below, are 10 steps that will help you achieve these objectives.

1. Get your response in on time or even early if possible. The FDA wants to see the response within 15 days, so plan your review and internal processes accordingly.
2. In the first paragraph, demonstrate your understanding of and desire to comply with FDA regulations.
3. Respond individually to each item addressed on the form. Give a corrective action and time-frame for implementing.
4. Prioritize by first addressing the conditions that will most likely affect product quality.
5. Outline how and when each deficiency will be corrected.
6. Avoid talking about whose fault the issue is or how it came to be. For example, keep a positive tone and indicate how the quality system will be improved.
7. Include any reference documents, such as purchase agreements for a new monitoring system or employment agreement for a new quality manager.
8. Keep in mind that there is a formal process available for you to dispute the findings.
9. Be proactive in addressing the conditions. For example, address why the deficiencies were not detected internally and what will be done to correct this condition.
10. Seek clarification with the inspector when you receive the 483 on the spot. Be sure you understand each objectionable condition before the inspector leaves the site. It may behoove you and your firm to seek out an industry expert if the matters seem complex or if the issues are not able to be resolved by your own personnel.

For the complete Form 483 article, click here.

In an ideal world, you welcome an inspection and view it as a learning opportunity. You also view it as a chance to tell your story and demonstrate your excellent quality systems, processes, and procedures designed to meet regulatory requirements. An automated monitoring and alarming system that measures accurately and ensures gap-free data can make your QA/QC programs more efficient, optimal and ready for any critical evaluation or inspection. The records and reports this type of system can provide may be ideal for a detailed response to quality concerns outlined in the 483 around measurement or monitoring. Preferably, this type of system would preclude objectionable conditions from the start.

The new Vaisala Veriteq viewLinc 3.6 software now integrates Vaisala Veriteq data loggers with Vaisala measurement instruments for a complete and robust Continuous Monitoring System that ensures gap-free data and helps prevent objectionable conditions caused by inadequate measurement or monitoring systems. The assurance from Vaisala’s new software can help programs be more efficient and ready for successful evaluations and inspections. To learn more about responding to Form 483 and Vaisala’s new software, visit Vaisala at Interphex 2011 (booth 2045), March 29 – 31, at the Jacob Javitz Convention Center in New York City.

Vaisala is a leader in providing comprehensive reliable, high-quality measurement and monitoring solutions in controlled environments within the life science industries.

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