By Mark Gunn
MGD Services
The FDA has performed a site inspection and they have issued your company a FDA 483 letter. Knowing how to deal with these legal documents (and these are legal documents) can mean the difference between eliminating potential problems or dealing with the agency in a seemingly unending stream of documentation and problems.
The response to a FDA 483 letter is your chance to tell your side of the story to possibly the only compassionate listener before Washington becomes involved. You must make certain the appropriate response will help your case and not hurt it!
The FDA investigator performing the site inspection and considering issuing a FDA 483 will attempt to verbally elicit your response to each concern, one by one. In cases where your responses can be made with certainty, you should make them. But if you are not sure, it would be better to explain to the investigator that you will supply a written response to the FDA-483 sent directly to the FDA office.
A Warning Letter differs from a 483 in several important respects. A 483 represents the observations of the inspection team (or lone investigator, if such is the case). A Warning Letter indicates that higher level FDA officials have reviewed the inspection findings and have concluded that the findings warrant further formal notification to the inspected company that FDA believes serious violations may exist.
Even if you respond verbally to the investigator on each concern, it is crucial for you to send in a written response immediately. This assures that your response is accurately provided to all interested parties, including the investigator’s supervisor and the compliance director - all of whom have a role in the decision process.
You should be aware that a Warning Letter is a FDA regulatory action. The FDA is now setting up a case against your company to take additional legal actions if the promised and proper corrective actions are not taken in an appropriate period of time.
Once the FDA 483 is issued, the only people to read it before additional legal actions against the company are recommended are the investigator's supervisor, the director of investigations and the compliance officer. If you and the investigator have a dispute during the inspection you cannot rely on the investigator to relay your position for you. It is your responsibility to state your position, and you must make the most of this opportunity in a rapid manner.
Your main objective, once you are issued a FDA 483 Letter, is to limit the financial and legal damage to the company and to get into compliance as soon as possible. If you show continued contempt for the agency and its policies, chances are you will be forced into compliance through further legal procedures, which will bring on increased expenses, the possible loss of business and harsh adverse publicity. Instead, if you show the FDA you are complying with the agency's policies without the need for further legal action; the chances are that the agency will continue to work with you to achieve compliance. Getting to this point can be attained by knowing your rights, operations, products and when to concede. The FDA's first indication that you know how to work with the agency is in your response to the FDA 483 letter.
Remember the FDA is looking to work with you to achieve compliance; you have to use this chance to let the FDA guide you and avoid additional problems.
MGD Services
The FDA has performed a site inspection and they have issued your company a FDA 483 letter. Knowing how to deal with these legal documents (and these are legal documents) can mean the difference between eliminating potential problems or dealing with the agency in a seemingly unending stream of documentation and problems.
The response to a FDA 483 letter is your chance to tell your side of the story to possibly the only compassionate listener before Washington becomes involved. You must make certain the appropriate response will help your case and not hurt it!
The FDA investigator performing the site inspection and considering issuing a FDA 483 will attempt to verbally elicit your response to each concern, one by one. In cases where your responses can be made with certainty, you should make them. But if you are not sure, it would be better to explain to the investigator that you will supply a written response to the FDA-483 sent directly to the FDA office.
A Warning Letter differs from a 483 in several important respects. A 483 represents the observations of the inspection team (or lone investigator, if such is the case). A Warning Letter indicates that higher level FDA officials have reviewed the inspection findings and have concluded that the findings warrant further formal notification to the inspected company that FDA believes serious violations may exist.
Even if you respond verbally to the investigator on each concern, it is crucial for you to send in a written response immediately. This assures that your response is accurately provided to all interested parties, including the investigator’s supervisor and the compliance director - all of whom have a role in the decision process.
You should be aware that a Warning Letter is a FDA regulatory action. The FDA is now setting up a case against your company to take additional legal actions if the promised and proper corrective actions are not taken in an appropriate period of time.
Once the FDA 483 is issued, the only people to read it before additional legal actions against the company are recommended are the investigator's supervisor, the director of investigations and the compliance officer. If you and the investigator have a dispute during the inspection you cannot rely on the investigator to relay your position for you. It is your responsibility to state your position, and you must make the most of this opportunity in a rapid manner.
Your main objective, once you are issued a FDA 483 Letter, is to limit the financial and legal damage to the company and to get into compliance as soon as possible. If you show continued contempt for the agency and its policies, chances are you will be forced into compliance through further legal procedures, which will bring on increased expenses, the possible loss of business and harsh adverse publicity. Instead, if you show the FDA you are complying with the agency's policies without the need for further legal action; the chances are that the agency will continue to work with you to achieve compliance. Getting to this point can be attained by knowing your rights, operations, products and when to concede. The FDA's first indication that you know how to work with the agency is in your response to the FDA 483 letter.
Remember the FDA is looking to work with you to achieve compliance; you have to use this chance to let the FDA guide you and avoid additional problems.
Mark Gunn has 25 years experience in the Quality Assurance and FDA validation fields. If you have any questions about these topics, please email Mark at
Posts
No comments:
Post a Comment