FDA has the mandate of ensuring the safety of the public by assuring the safety of drugs and medical devices among others. To this end, FDA officials occasionally visit manufacturing establishments for the purpose of carrying out an inspection to find out whether or not the establishment is in compliance. After an inspection, FDA officials may issue FDA 483 and warning letters. Sometimes, the manufacturer may receive an FDA 483 form without a warning letter.
It should be noted that the decision to issue FDA 483 observations or both the FDA 483 and warning letters depends on how well the manufacturer has complied with the FDA requirements or the degree of violation. While both the FDA 483 observation form and the warning letters are issued when the firm is found to be in violation of FDA requirements, the warning letter indicates that the company is in gross violation.
Once an FDA 483 and warning letters are issued, they result in very undesirable consequences that any manufacturer would want to avoid at all costs.
Firstly, issuance of an FDA 483 and warning letters may lead to negative publicity especially in this age of social media. As a result, the reputation of the concerned firm is damaged in a short time as customers get a negative impression that it is not keen on their safety. Customers who would have otherwise come back to deal with the firm may want to reconsider their decision. Usually, many customers may not take the time to find out the nature and extent of violation that led to the issuance of the FDA 483 and warning letters.
Related: Tips to Reduce 483 Observations
Secondly, closely related to negative publicity is that competitors will in most cases leverage on the fact that a firm has been issued with an FDA warning letter as a way of wooing its hitherto customers. In today’s society where each company seeks to present itself as the best to increase its market share, this kind of conduct is expected. As a result, a firm receiving an FDA warning letter will have to fight hard to retain its market share, even then, a substantial loss may be inevitable.
Thirdly, the company may most likely be distracted and stagnate for some time. Where a young company is issued with the warning letter, some of its staff may choose to move to other companies with a better reputation. Nobody would want to be associated with a firm that does not comply with the law as they consider this as detrimental to their career prospects. Even where staff may not shift to other competitor companies, they may end up spending a lot of time in seeking to remedy the wrongs and bring the firm on track. Consequently, little energy is devoted to innovation. There will be no new products, and the firm may be outsmarted by competitors who spend their time improving on their products.
While these are some of the most drastic consequences of getting an FDA warning letter, there are much more which also have undesirable effects such as loss of contracts and dissatisfaction of the stockholders.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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