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How to Respond to an FDA Warning Letter or 483(s)
The FDA writes warning letters in response to violations of the Federal FD&C Act, or other acts. Failure to take prompt appropriative, corrective/preventive action can result in enforcement action without further notice.
This action may take the form of:
- Injunctions,
- Civil Penalties
- and possibly Criminal Prosecution
If your organization gets a warning letter consider it a serious threat to your company. In recent years the FDA has relented somewhat in their issuance of this form of notification but there is indication that the practice may be on the rise. Organizations who receive them have seen their stock drop dramatically. The cost of not actively working to prevent FDA warnings can not be underemphasized enough.
483s
Receiving a 483 is in itself a mild slap on the wrist (compared to receiving a warning letter). However, an organization must take the observation serious. Failure to correct problems identified by the FDA can in itself lead to warning letters.
ADDRESSING FINDINGS:
483s
Receiving a 483 is not the end of the world! It happens. It is analogous to receiving a finding on an internal audit – how many times does that happen! However, it is important to respond to the observation(s) in a concise manner.
First, a 483 is called that because it is the number of the form the FDA uses to address observations – not to be confused with 482 which is the form the FDA gives you at the beginning of all audits. The observations will be listed on the 483 form.
Address Every 483 Item
It is important to list the observations individually and respond to each and every one. Some observations may be listed together in a string of sentences. It is important to pull out each separate requirement/deficiency and then to respond.