September 26, 2017, Lakewood, Colorado – The FDA has the authority to visit a manufacturer to inspect their facility and verify that all processes are compliant with any applicable regulations. If the FDA inspector finds anything of concern, they are required to document those findings. This official documentation is done on Form #483 – also known simply as a “483”.
The information captured on the 483 is the inspector’s observation. The information captured on a 483 is not a final decision from the FDA that a company is in violation of any regulations. The company receiving a 483 has 15 days in which to review the finding(s) and respond to the FDA with a course of action to correct the finding and/or to ask for clarification of the requirement being cited.
It is necessary for the organization to then investigate and perform quality due diligence to support and document the process or facility in question. It is imperative in this data collection to provide the FDA with a conclusion and follow-up plan. The Form 483 Investigational Observations issued most commonly for poor or ineffective resolutions are due to a poor or nonexistent investigation process by the offending-organization.1
The 483(s), along with the Establishment Inspection Report (EIR) and supporting documentation from the visit, are presented to the FDA for further evaluation. With these details, the FDA will determine if any additional steps are required to protect the health of the public. Should any further actions be necessary, the FDA will issue the company in question a Warning Letter. The Warning Letter is an indication of serious violation(s) by the company. Depending on the severity of the violation(s) and the responses provided by the company, product approval for could be withheld or even a forced closure of their facility, causing long-lasting damage to a company’s reputation and brand.
Sources:
1 http://www.pharmtech.com/avoiding-investigational-failurediscrepancy-related-form-483-observations