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Observing FDA’s Form 483 — A Closer Look

What is Form 483?

The FDA is responsible for protecting the public by ensuring their safety and health in consumption of regulated products. For that reason, the FDA is required to inspect the facilities of manufacturers or processors of these regulated products. The form the FDA uses during these inspections if issues are found is known as the 483.

The FDA handles inspections on their terms, coming unannounced at any given time. At the end of the inspection, the inspector presents an Establishment Inspection Report (EIR), which must be analyzed by the internal Quality management team being inspected in pursuance for compliance. In some cases, violations to the Food Drug and Cosmetics Act may be noted. The team then presents a Form 483 along with the EIR.

This is not a death sentence. Quite the opposite, if you think about it. It is merely a graded test. You get comments and marks after a test, right? If the teacher proposes some improvement, it does not mean that the entire semester is a burst. The Form 483 is a way for the inspection team to say- hey, you are good, but there are points of concern. Before the FDA inspector leaves the facility, make sure you fully understand the observations and comments on the 483 form. It ensures that your Quality team can respond efficiently post inspection in 15 days. To fully understand the scope of the form 483, there are a few things to consider:

Structure

On that graded test, you receive a comment that urges improvement without explanation. The 483 documents the issue(s) found during inspection. The comments are always in detail and should have clear explanation. If there is confusion, ask questions. The observations should be taken seriously. The goal of the 483 is to make sure the facility meets FDA compliance and ensures 100% quality. The FDA is there to investigate and rectify the issue. During investigation, the organization may also realize that there are other issues not noted by the inspection team. In this case, let the example thing go. Also, work on addressing the unnoted violations internally post inspection.

Take Action

It is said that if the 483 is short and precise, one should not worry too much. The issue comes in when it is lengthy with a host of issues being documented. It’s imperative to let the inspector know your facility plans to address these issues immediately. Short or long, it must be addressed. Ignorance of a 483 may lead to a warning letter which has mandatory requirements and will be made public. It’s a wise choice to always address the 483-post inspection or you are looking at a death sentence.

What to Look Out For

Any issue is worrisome, but some observations should be viewed with severity. One of those is data integrity issues. If data is compromised, it means that various parts of the organization are vulnerable. Multiple aspects of the entire outfit must be put under a microscope. This is the worst possible issue as it may threaten the integrity and reputation of the company. 483 forms are considered a standard part of an FDA investigation. Care should be taken with concern to data integrity issues.

Imagine being one of the best students in a program only to get citations for plagiarism and cheating. That ruins credibility and calls into question your academic standing. Right? This is the setback a data integrity issue observation could cause.

The Death Sentence

Know the differences of a 483 form and a warning letter. A 483 is a report on the deficiencies of the organization regarding compliance. It is presented by the FDA team at the end of an inspection. A warning letter may be the last step before enforcement action. It is also the step after ignored 483s. It is presented by higher FDA officials and not the inspection team.

Imagine a guy with hefty debt. The bank sends him notification of late payments and warning of further action. This is the 483. The guy decides to ignore the letters and not pay, the bank sends someone more muscular. The auctioneers. They send a letter of their own. This is akin to the FDA warning letter. If this is also ignored, they send in someone to audit the assets that the guy put up as collateral. He is given notice that his house will be seized in 14 days. This is enforcement action.

Free for All

These form 483s are available under the Freedom of Information Act. Only proprietary information is redacted but otherwise anyone can look up a company he or she has stake in. Stake does not necessarily mean shares. All internal Quality teams that require FDA compliance and regulation should understand the 483 fully. Be cognizant of the issues being noted by the 483, and always reassure the inspector that the issues will be addressed and make your plan of action for a 15 day follow up immediately.