FDA is trying out a new procedure in lieu of an onsite audit during the pandemic. Dental laboratories may receive a letter from FDA requesting them to participate in a compliance assessment.
The assessment is performed remotely through video conferencing. The assessment is voluntary and is conducted very much like an onsite audit. An inspector reviews conformance to FDA’s Quality Management System by reviewing documentation and asking questions of management personnel. Since this is an assessment and not an official audit, there are no official findings recorded in an FDA Form 483. Participation in the assessment would find areas that the lab could improve prior to an official onsite audit. If the assessment format works, it may prove to be a way for FDA to engage facilities in the future to minimize the costs of having to actually visit the facility.
Don't forget to review your FDA registration for this year. Learn more.
Have questions about your dental lab quality system or need FDA compliance assistance? Contact us for assistance to learn more about how we can help your dental laboratory.
How to Achieve Dental Lab OSHA Compliance
Learn more about what SafeLink Consulting can do to help your business with compliance services, including safety compliance, to meet OSHA training requirements and quality system consulting to meet FDA compliance. SafeLink Consulting assists businesses with workplace safety training, infection control training, HIPAA training online, quality systems, assessments, audits, due diligence, and more.
Industries include:
Dentistry compliance - assisting the dental practice with meeting requirements for OSHA, HIPAA, EPA, and CDC guidelines, patient safety and employee health & safety
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