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
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
- In the
first paragraph, demonstrate your understanding of and desire to comply
with FDA regulations.
individually to each item addressed on the form. Give a corrective action
and time-frame for implementing.
by first addressing the conditions that will most likely affect product
how and when each deficiency will be corrected.
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.
any reference documents, such as purchase agreements for a new monitoring
system or employment agreement for a new quality manager.
in mind that there is a formal process available for you to dispute the
proactive in addressing the conditions. For example, address why the
deficiencies were not detected internally and what will be done to correct
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
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.
is a leader in providing comprehensive reliable, high-quality
measurement and monitoring solutions in controlled environments within the life