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hzy2 started the topic Form 483 in the forum Quality Control and Quality Assurance 6 years, 6 months ago
Dr. Simon mentioned in this week’s lecture that FDA can issue Form 483 to a company if its practices are not in compliance with the rules and regulations set by them. He gave the analogy that having Form 483 issued is like receiving a speed ticket that gets posted online and everyone finds out about it. This hurts the company’s reputation with customers and could even result in shutting down of the company. If companies are aware of this risk then how come some of them still fail to adhere to the rules? What can FDA do to prevent all of this from happening in the first place?