As a medical device manufacturer, you are likely all too aware of the looming threat of that dreaded FDA Form 483. This letter indicates that an the investigator(s) has observed conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts or objectionable conditions found during inspection.
nIn a highly regulated industry, managing the everyday manufacturing process can be challenging enough. Tack on the added burden of this quality management nonconformity, and youu2019ve got a constellation of headaches and complexities that may prove too much for your in-house resources to handle. At the same time, the cost of nonconformance is too high to ignore.
nHow you respond can make or break the integrity of your company. Weu2019ve got your back! Weu2019ll help you quickly respond to the notice and address the violations in question.
Contact Us
FDA Form 483 Support:
We will assist you through your nonconformanceu00a0complexities, ensuring you act quickly and proactively to resolve the issues in question.
With our QMS Compliance and Remediation Services, weu2019ll partner with you to:
- Analyze the findings of the FDA Form 483
- Develop a nonconformance management procedure to address the deficiencies
- Create a timeline for implementation
- Lead or assist in the implementation of the plan to address the deficiencies
- Act as an interim management representative
- Field questions from you or the FDA during corrective action activities
- Develop a nonconformance standard operating procedure to ensure ongoing QMS compliance
Turn it over to Sterling
With our QMS Compliance and Remediation Services, you get a partner with decades of experience helping clients achieve and maintain regulatory compliance. Let us take on the burden of dealing with those dreaded u201cfor-causeu201d inspections and nonconformance findings, and rest easy knowing youu2019re in capable and experienced hands.
To learn more about how Sterling can help you address the FDA Form 483, fill out the form.
