The company’s SOPs in Quality Control (QC) should ensure meeting all regulatory requirements for their medical products, and should include preventative actions to ensure avoidance of receiving a Form 483. An assumption of mine would be perhaps the company is new to the industry and is still developing its quality procedures, or from the other spectrum, the company is too large to ensure quality control. Although, the FDA does update their regulations periodically to ensure each medical company is aware of the regulatory guidelines that pertain to their products and there are several ways a company can avoid red flags in an audit. It can be as simple as training – the company ensures that each department is properly trained, skilled, and tested. The company can identify specific roles for audit preparation and for during the inspection. Management can ensure updating procedures and training sessions on a periodic basis. Provide motivation through seminars to have employees in the quality control department to work collectively on ways for improvement and identifying preventative actions or lessons learned. Lessons learned is actually a very important and critical aspect that I have seen in the medical industry. It not only improves the good practices in place, but it can also be used as a tool for new projects or new employees to better understand the history of the company’s product portfolio and SOPs. There is a saying that we have at my company which is: work as if you are to be audit ready every single day. Keeping that mindset helps ensure you are always following regulations and good compliance practices on a daily basis.

I do agree with you, but from my experience that even when the SOP is correct and up to the standers, sometimes it is a production issue that by human mistake is not following the BOM list and SOP even though everything is defined very clearly. SO I think it is hard to eliminate any mistakes by locking the SOP or have a preventive action on it. Also sometimes you have to come up with a solution that meets customer requirements but doesn't fully fulfill the standers rules. For example, in my current company, they build DRAM for a mission-critical application that required a special connector that does not full JDEC. in this case, it was built for this special project but we could not market the product as stander product like can be offered for other customers. For this case, it is not a medical device or life-threatening which is okay but I don't think it will be like that for FDA.

Having awareness of a risk does not necessarily guarantee that it will be averted. Going along with the analogy Dr. Simon mentioned, if getting the form is similar to getting a speeding ticket, drivers are aware that speeding will result in them getting a ticket or worse from a police officer if they get caught. Being aware of the risk does not guarantee that it's not going to happen. Admittedly, the analogy falls apart here for the reasons the repercussion happened, but I think that gets the point across. From working in the industry, I know that in fact medical device manufacturers do all they can in order to make sure they abide by all the rules and regulations that the FDA and other regulating bodies impose. A common practice is often having internal audits and reviews in addition to high quality standards. During these, auditors/reviewers will look for things that the FDA might look for in compliance/non-compliance. The good thing about doing this is that should something slip through the cracks, it's caught by the company who can correct it with much less consequences than if the FDA caught it. Still, human error can often persist to the point that errors and non-conformances slip past all these checks and standards and results in getting Form 483 or any other repercussions that the FDA might issue.

Although it is cynical I think there exists one reason and one reason alone that companies do not strictly follow the FDA guidelines and do not change their protocols, money. If we continue with Dr. Simon's analogy of the speeding ticket, yeah it hurts the reputation but people are very quick to forget and there is so much money to be made that companies simply don't care. If I know that the speeding ticket will be $100 but by speeding I will make $200 but would only make $90 if I didn't speed then why would I not speed. If I don't get caught then I'm making $200 and if I do then I make $100. It's more either way. As much as it would be nice to think that these companies are always acting in good and ethical ways we need to look at the reality that these companies are run by businessmen who want only money and to grow the stock price of the company. They will cut any and all possible corners short of killing patients in order to increase profits. If they know all they will receive is a slap on the wrist then there is no way they are going to be compliant with the regulations. As long as their product aren't killing people then they won't care. The only way to make punishments stick is to hit them in the bottom line, so to do that the FDA would have to raise the amount companies have to pay if they receive a Form 438.

At present, Form 438 seems to be ineffective in assuring that companies to comply with the rules and regulations set by the FDA. For both cases that are stated above, inexperienced companies are companies that may be too large to keep organized, a separate third party regulator may be the proper solution. Often times a company's own regulation department can be biased, or inexperienced, so instead of making mistakes at the beginning the FDA can require companies to have other people set up the quality assurance of their products. These people will be people who work for the FDA and can help the company put a strong system in place. This will allow companies to get familiar with the standards that are required by the FDA. The employees should also be trained on how to respond to a Form 438 and how to address each of the observations listed on it. The goal of the FDA is to promote compliance so it is important for companies to believe that the FDA is there to help them, not to punish them. However, harsher penalties should be put in place so as to deter companies from trying to get away with noncompliance.

I don't believe companies intentionally want to fail to adhere to the rules. With the analogy of the speed ticket, for instance, let say you are rushing to get somewhere and unfortunately get pulled over and get a ticket. I don't think your goal was to get one; perhaps you were hoping you might go unnoticed. We are all flawed in that way; sometimes we do stupid things hoping we might go unnoticed. The same reasoning can be applied to companies. There are instances where companies get caught up and fail to adhere to regulations in hope that it might go undetected. Indeed some missed regulations do go undetected.
However, I believe should try their best not to depend on luck. The Quality Control (QC) should ensure adhering to all regulatory rules even if it means disagreeing with others. Like Dr. Simon mentioned, the research scientists tend to have a hard time adhere to regulations if those regulations don't equate with scientific norms. I think management should periodically set up meetings to provide updates on current procedures and regulations.

 Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act. Form FDA 483 " Inspectional Observation" is a form used by the FDA to document and communicate concerns discovered during these inspections, and do not represent a final agency determination regarding a compliance. A recipient of a 483 should respond to the FDA, addressing each item, indicating agreement and either providing a timeline for correction . This response must be submitted within 15 business days regardless of the number of observations.

Form 483 is officially called as Notice of Inspectional Observations or simply “483”, which is issued by Food and Drug Administration at the conclusion of an inspection if some company had significantly  violated FDA regulations. Form 483 are discussed with a company’s management at the end of the inspection. Each observation is read and discussed so that there is a full understanding of what the observations mean. When a company receives a FDA warning letter, it must ensure to correct the problem and inform the FDA of the specific plan for the correction of the problem. 

I have seen all kinds of people over the years and can safely say that how they carry on day to day, specifically in terms of cleanliness, varies significantly. This is a much smaller scope than what would be experienced in a full work environment, but I have seen both meticulously clean people and obscenely messy people in a lab setting. I'm not saying that this transfers directly into a company, but it is more the idea that on a personal level some people are not concerned with the negative possible outcome, despite knowing the health and safety violations of a messy lab space, because it does not benefit them in the moment to keep the space clean.

In a larger setting, I would agree with what others have said that money plays a part in causing companies to ignore the possibility of being issued a 483. And that would probably be more so when dealing with less established companies that are trying to compete with well-known companies as they do not have the finances or time to ensure everything is running as it should. It could also come down to the idea of rolling a small snowball down a snow covered hill, or more specifically the term "slippery slope". Oftentimes people will start off with small excuses or they'll cut a corner by an insignificant margin, but as time goes on people become more comfortable with their misdeeds and without realizing they're telling full-blown lies and stealing money from retirement funds. If we go with the speeding analogy, I'll admit to times where I've gone a decent margin above with the initial idea that I'd only go a little faster to get to where I was going sooner before realizing that the little faster turned into a lot faster. I can't speak for companies, but it's possible some started with the intent to skirt the regulations by a little bit in order to save on costs that evolved and grew as time went on.

Companies fail to adhere to the regulations set by the FDA even with this form because maybe it takes longer time than usual to improve these mistakes. It might not be intentional for these companies to keep breaking the rules, but we need to understand that managing or running a business is not easy; it comes with many risks and complications. A notice from the FDA is a good start for companies to look back and fix the rippling mistakes. One person working for the company and is not committed to the services, is enough to have the company in trouble by the FDA. Companies need to figure out where the problem emerged from in order to fix it, and maybe that's what companies have a hard time finding, and causes them to appear as if not adhering to the rules. Also, if these companies do not take advantage of the notice sent by the FDA, then the FDA has the right to send higher warnings or big amounts of tickets to be paid by the company. And if that didn't work, then make it even higher the next time until there are no more chances for warnings. This method should be effective in maintaining a lawful workplace or the business can shut down if it doesn't adhere to the regulations.

I think companies may continue to not follow the rules even if they have a risk of receiving a 483 for the same reason that people continue to speed on highways even when there is the risk of getting a speeding ticket. There is always the chance that you will not get caught. 

While absolutely terrible, it is cheaper for companies to not follow guidelines and to cut corners. It saves money, people, time, and allows for the product to be made and sold at a faster rate than other companies that are following said guidelines. I think when people are greedy enough, it's easy to justify doing such. 

In terms of the FDA preventing this, I think maybe the FDA could incentivize workers to whistleblow when they see such practices occurring. They would need to offer some kind of award that is worth the risk of being blacklisted from the industry though, as whistleblowers are not always treated kindly by the companies or industries they are whistleblowing on. 

Otherwise, I am not sure. Maybe give financial awards to companies that maintain high standards? 

A Form 483 is given by the FDA when a company fails to comply with the practices set in place by their own Quality Management System (QMS) or the FDA's standard regulations. I believe the analogy of receiving a speeding ticket that gets posted for everyone to see was intended to speak to the blow taken to the companies reputation; although, the act of speeding is a much more straight forward and intentional way of breaking the law than that of a noncompliance issue within a medical device company. I do not believe companies regulated by the FDA are noncompliant on purpose. Because it is known the FDA will come to do an audit eventually, it would not be a smart business decision to believe that the company can get by without being caught. It is also a known possibility that the FDA can come in and shut down the company if significant noncompliance is found, however, we are all aware of the effort it takes to get a medical device company off the ground in the first place. It is hard to think a company would than purposefully jeopardize that for the FDA to come in and shut them down. There are many cases of a company being too large or too inexperienced to adhere to the rules set. It is therefore imperative that a company performs frequent internal audits and has an established CAPA (corrective and preventative action) system in place to continuously check and correct for noncompliance issues throughout the company. 

The Form 483s are available under the Freedom of Information Act but may be redacted to remove non-public information. The FDA usually publishes select 483s on their website at this location: ORA FOIA Electronic Reading Room; you can find of recently issued 483s are available in ORA's Electronic Reading Room. Questions regarding Inspection Observations may be directed by email to FDAInspectionsObservations@fda.hhs.gov

The Form 483 reminds me of this one case study I learned about, which had to deal with Harvard and some medical tests they were doing. The case study was based on the fact that Harvard was conducting clinical trials years ago, before standardization of procedures was in place for many. There were several issues that Harvard had to address, such as animals not being labeled and animals not being locked, so traceability was impossible. Multiple tests were done several times to have passing results, among other infractions. Then Form 483 was issued, and this wasn't a surprise; many of these issues were logical, and you didn't need a PhD to know that this isn't how research is done. Harvard blatantly didn't correct these issues because they were at the top of the food chain, so to speak, in research. This wasn't even a company that had the resources to address these issues, but Harvard thought they could get away with them. This is the same thought process that many companies have: that the FDA will not find out, and the outcome justifies the means. The FDA prevents these issues from happening by publishing a multitude of instructions on how to conduct research as well as guidance, namely in the Code of Federal Regulations, on how to approach a vast number of topics. The FDA doesn't want to stifle research but wants to provide bad research that could get someone hurt in the process. Form 483 is one of the ways that the FDA corrects these issues to let the company know about them and to correct them before they become available to the market and the public.