As a medical device original equipment manufacturer (OEM), you already know that staying in compliance with the United States Food & Drug Administration (FDA) regulations requires being on the ready for unannounced visits from FDA inspectors.

However, with today’s increased regulatory scrutiny on the whole medical device supply chain, your company isn’t the only one that needs to stand ready. Your medical silicone molding supplier needs to be ready as well.

Day-to-day compliance to 21 CFR Part 820 is not just having “i’s dotted and the t’s crossed” on paperwork. Due to today’s advanced structure of global supply chain management and converging quality standards, it becomes increasingly important to have all plants compliant as a bare necessity.

In this article, we’ll focus on four ways to encourage your medical silicone molding supplier to become FDA ready; that is, if they aren’t already (but like ProMed, they already should be).

Fostering a Culture of Compliance

Your medical silicone molding partner needs to actively and continuously foster a culture of compliance throughout their entire organization. This includes training and empowering employees to speak up when they notice noncompliance. This helps the entire organization quickly find and resolve potential compliance issues before an FDA auditor might. A real culture of compliance motivates all employees to follow the required regulatory requirements applicable to their daily work, and thus minimizes the likelihood employees will cut corners, ultimately reducing your noncompliance risk.

A true culture of compliance extends beyond just following the regulatory rules. Encouraging personal development & growth, and ensuring that each employee has the skill sets necessary to perform their jobs, must also be a priority for your supplier. Like so many other things, the proof is in the procedural output, which naturally leads us to the next critical area: Training.


Digital and paper proof of hands-on training, procedure training meetings, and even online training must be consistently and accurately recorded. Especially records for the training required at regular intervals, like annual safety training or gowning procedures for cleanroom operations. It must also be triggered from the introduction of a new manufacturing process, or the production of a new customer product.

All employees must also familiarize themselves with their quality management system (QMS) documentation in order to implement the policies and procedures in their work. FDA and even customer scheduled auditors can, and do, quiz those on the shop floor about their company’s SOPs, quality policies, and FDA’s quality requirements.

Meeting Standards

Of course, employees are much more likely to accurately recall both their company’s quality policies, and the applicable procedures that adhere to FDA rules, if all procedures and processes are written and performed with FDA inspections in mind. This is one key reason why medical device OEM’s and medical suppliers achieve an ISO 13485 certification: if the companies can demonstrate that they consistently are performing and conforming to the FDA’s Part 820 requirements, and that they strive to continuously improve their processes to achieve and even exceed ISO 13485 standards, it virtually guarantees their compliance & re-certification. And it also means that if they stay vigilant, they shouldn’t really have to worry about an FDA auditor stopping by unannounced.

As part of your own supplier quality performance program, you should ensure your medical silicone molding vendors all have these practices as a priority.

Internal and Customer Audits

In addition to your silicone molding vendor’s own internal audits, and those of its ISO registrars (if they’re ISO certified), your audits can also help keep this critical supplier on their toes and compliant, minimizing your own regulatory risk as well as ensuring the quality and safety of your products.

Internal, registrar, and customer audits force suppliers to maintain and demonstrate regulatory and quality compliance in practice (and not merely on paper). As much as reasonable, these audits should mimic the regulatory ones. If an FDA auditor were standing over the shoulder of each of your silicone molding vendor’s employees, what would they see?

Wouldn’t you want to find out before the FDA does?

The Cost of Not Being FDA Ready

If your medical silicone molding supplier isn’t ready for an FDA audit, it’s very likely that significant negative findings will result, or worse, that supplier could fail the audit and be shut down, leaving you without crucial components. There is a serious business cost to FDA non-compliance.

ProMed’s customers need not worry about that. As a medical silicone molding company passionately focused on the quality of our people, processes, and products, we are always FDA ready. Which means we are always ready to partner with you.

Is Your Medical Silicone Molding Company FDA Ready?
Article Name
Is Your Medical Silicone Molding Company FDA Ready?
As a medical device original equipment manufacturer (OEM), you already know that staying in compliance with the United States Food & Drug Administration (FDA) regulations requires being on the ready for unannounced visits from FDA inspectors.
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ProMed Molding
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