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1) How do I respond to FDA Form 483?
What is the significance of FDA Form-483?
Response to the FDA 483
Who Checks the Checker?
2) How do I respond to a warning letter?
3) How do I respond to a license suspension?
4) How do I perform a 510(k) submission?
Response to the FDA 483
by Mary Ann Tourault
When an Investigator issues an FDA-483 at the conclusion of a Food and Drug Administration (FDA) inspection, it is always wise to send a written response to the items listed on the 483. There is no rule or law that requires a formal written response to the 483. However, since most firms do send a written response to FDA, it has become an expectation.

The written observations constitute the inspection's determination of statutory violations. If they are not rebutted in writing, these observations provide a one sided and biased administrative record about your establishment's actual compliance and philosophy for attaining and maintaining compliance.

The items on the 483 represent the views of the investigator, and it is very important for an establishment to examine the findings. The written response is a statement to FDA that management will correct any problems noted during the inspection. After determining what corrective and preventive action is indicated, the response outlining your actions should be sent to the local District Director.

A number of articles have been written that address the essentials of how to write the response. The single most important way to respond to the 483 is to provide accurate information and to be clear and concise. FDA wants a description of how a deficiency will be corrected - not a historical narrative. Many responses give needless detail and this does not help your establishment or the FDA. Stay on point, and be precise with the language used.

Do not wait until every detail of the corrective action has been decided or performed. Send a plan of corrective and preventive action to FDA as soon as is feasible. An establishment is not locked into a plan of corrective action, as there are times the first ideas simply do not work to prevent recurrence. When this happens, send in the current plan of corrective action to the FDA.

Examine the observation and determine the significance. If the FDA found a serious problem, it is important to correct the problem immediately. The immediate correction may not be what is needed for a permanent solution.

It is very important to frame your response with how errors were observed and include how many times you perform this task. If an error was found 1 of 500 times the task was performed, this is important to note. In some instances the investigator does not review enough records to gather a true sense of the overall numbers. It then becomes important for the firm to gather the information and put it in the response to the observation. The important point to determine is, was the event a routine occurrence or was it an isolated incident?

In the first paragraph of the response letter, provide a statement that your establishment understands the need to comply with FDA regulations. If your intent is to follow the law and create a good working relationship with FDA, it is vital that the promised corrective and preventive action is performed in a timely manner. It is difficult to set an exact reference for what may be considered timely. Sooner, within reason, is always better when setting a time frame.

A previous 1992 article in CITINGS®M. written by legal counsel, E.M. Miller, Jr., Attorney at Law, provided five "Golden Rules" for responses to FDA 483s:

  1. Avoid use of language that implies an admission of fault.
  2. Use your response to make a positive statement, rather than reacting to the observation.
  3. Respond only to the particular matter cited.
  4. Do not include irrelevant or gratuitous information in your response.
  5. When you're right say so!
The last Golden Rule is a most difficult matter. How should you tell FDA the observation is not correct? Before one disputes a 483 observation, be certain of the facts and the law.

This article first appeared in the April 2002 issue of CITINGS®, a publication designed specifically for the blood and biological source organizations. CITINGS INFORMATION EXCHANGE® is a not-for-profit membership network facilitating the anonymous exchange of inspection experiences for over a decade. For additional information about the program, visit our website at rrix.com, or call 804/741.9229. An information packet can be requested through e-mail at rri@richmond.infi.net.

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  Who Checks the Checker
by Mary Ann Tourault

At the conclusion of an FDA inspection, many times the Investigator issues a FDA-483 to list the observations noted during the inspection. There is no guarantee that an item listed is a true deficiency from regulations or a deviation in Current Good Manufacturing Practices (cGMPs). The observations noted are one person's opinion, which should be based on documented evidence.





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