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.