The consequences of not submitting FDA Warning Form / Letter 483 with the appropriate corrective action can be potentially catastrophic for a life science manufacturing facility.
An inadequate response can cause the FDA to escalate problems, resulting in hefty fines, closure of facilities, and even criminal prosecution. The prospect of a renovation project big or small can at least be overwhelming.
You can look at Wizmed for recent FDA site inspections.
483 oversight is issued by FDA inspectors after the audit of the company's manufacturing facilities. The document describes violations of Good Manufacturing Practices (GMP) and other related actions associated with the manufacture of appropriate drugs, equipment, food and cosmetics in the United States.
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Observations are listed in order of importance and monitoring is not always complete. Therefore, you may need to contact the FDA to better understand the overall audit.
The keys to a successful remediation project are efficiency and accuracy. The company must solve problems at a high level and solve them quickly. To implement an effective remediation project, companies need to follow a strict step-by-step plan of action.
As an expert in the field with a long history of assisting life science companies with remediation projects, Proclinical suggests that when developing a plan, companies take into account the following, taking into account the many different aspects needed for a project to be successful.