Thursday, February 6, 2014

Tips for Responding to FDA Form 483

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 information

can be found in section 5.2.3 Reports of Observations of the IOM. The 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 or her interpretation of

what is “significant” and what is minor. Nevertheless, the issuance of

“written inspectional observations” is required by law when an inspector

finds a possible deviance from federal regulations.

Form 483s v. Warning Letters
It’s likely that the day comes when your firm receives a 483; naturally

you want to cooperate fully with the FDA in addressing the objectionable

conditions listed therein. One thing that you should be clear about is that

this is not a ‘Warning Letter’; it’s more like an offer to help you resolve issues

and improve your quality system. To be clear on the process: the FDA may

or may not issue a formal warning letter if you do not show that you have

addressed the observations within the 483 to the agency’s satisfaction.

However, it’s an important distinction to note that receiving a 483 does not

necessarily mean you are out of compliance.

10 steps to an effective 483 response
Your 483 response needs to accomplish these three things: establish credibility, demonstrate acknowledgement and

understanding of the observations and the associated requirements, and show commitment to corrective and preventive

actions. Below, are 10 steps that will help you achieve these objectives:

1. Get your response in on time or 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 of your response, 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. Your firm may decide 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.

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