So what’s with this 483 audit form and where do I go from here?
Faced with a 483 audit form? If this is the first time your company has received a document of this nature your initial thoughts may be… now what? In order to understand the true implications of a 483 citation, it may help to think of it in terms of a speeding ticket. It’s a road block or a cause for reevaluation of your current state. Although not necessarily a serious offense, it’s an important warning to your company that should not go unnoticed.
A 483 audit is issued after the conclusion of an FDA inspection. This form states that certain conditions were cited as “in violation” of FDA standards/regulations. The FDA investigator feels that the practices or conditions surrounding the product at hand is in question and therefore a change needs to be set forth, in order for operation to continue.
A company must understand the problem at stake as well as the violations that are in play as a way to avoid an escalation, like a Warning Letter, which is much more severe in nature.
Yet, fear not. You will not be left in the dark after receiving this 483 audit form. The FDA will also provide a detailed written report, spelling out the specific reasons for the audit known as an Establishment Inspection Report, as well as all evidence or documentation that was extracted while the investigator was onsite. From there, depending on the severity of the case, the Agency will determine what kind of action will need to take place.
If you receive a 483 Citation and are not sure what to do next, make sure to reach out to experts in FDA consulting services…a group you can trust. The professional team at Smart Pharmaceutical Consulting has many decades of experience in remediating FDA compliance issues. Give our team a call today. We look forward to helping your company reach a positive solution!
* The above facts noted, regarding 483 citations, were referenced from the FDA’s website. For more information or facts on 483 Citations/Warning Letters please visit: http://www.fda.gov/ICECI/Inspections/ucm256377.htm