Now that the pandemic has subsided, government regulatory agencies are back in business. FDA has hired many new inspectors and inspections are in full swing.
We have seen more dental laboratory inspections this year than all of the last three years. Registration with FDA will prompt an inspection at some point in time usually based upon the risk of the devices being manufactured. The focus of any inspection is the Quality Management System that is required for all medical device manufacturers.
There are red flags that may initiate an inspection other than registration. If a facility advertises an activity that may be viewed by FDA as a regulated function, at a minimum FDA may ask for an explanation and may initiate an inspection. Some common registration issues may also prompt inquiries from FDA. A common issue is registering as a manufacturer when actually the facility is a contract manufacturer. The manufacturer is usually the 510(k) holder.
While the Quality System would be the focus of the inspection, registrations would be reviewed as part of the process, so it is important that the listing information is correct. SafeLink Consulting can help develop and implement a Quality System for your facility. If you already have a Quality System, then SafeLink Consulting can provide an audit by a Certified Quality Auditor that would meet FDA’s requirement. Contact SafeLink Consulting for help.
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Have questions about your dental lab quality system or need FDA compliance assistance? SafeLink Consulting can assist your business with developing a Quality System and Good Manufacturing Practices - GMP for medical devices manufacturers including the dental lab, workplace health & safety training, infection control training and HIPAA training online, plus more.
Learn more about FDA Dental Regulations.
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
Dental Laboratory compliance - assisting the dental lab with meeting requirements for OSHA, FDA, and CDC guidelines, employee health & safety, plus FDA requirements for lab manufacturing custom implant abutment /gmp for medical device manufacturers
Medical Device Manufacturers compliance - assisting with meeting OSHA compliance & FDA requirements, GMP - good manufacturing practices
General Industry compliance - assisting with OSHA compliance and FDA compliance as it pertains to the specific business
Beverage Industry compliance - assisting beverage businesses such as the craft brewery, winery, cidery, distillery, vintner with meeting OSHA compliance, health & safety,FDA requirements / CGMP - Current Good Manufacturing Practices, and FMSA - Food Safety Modernization Act (FMSA).
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