Laser Dental Innovations FDA Warning (2018)

Detailed Analysis

False Claims and Regulatory Violations

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 1219 Quail Creek Circle, San Jose, California from December 4-14, 2017. During the inspection, an FDA investigator determined that your firm is a manufacturer of the dental handpiece and laser fiber optic surgical devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

1.    Your firm failed to establish procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

Your firm’s “Corrective and Preventive Action (CAPA)”, document SOP028A dated December 20, 2006 states your firm will document your CAPA activities on a Corrective Action Form (FRM 017) and will include the details of the investigation, a root cause analysis to identify cause, corrective actions taken, list of impacted records, and an appropriate method for verifying effectiveness of the corrective actions.

Potential Health Risks

Office of Medical Device and Radiological Health OperationsDivision 3West19701 FairchildIrvine, CA 92612

a.  Your firm's "Risk Management" procedure, SOP008A, dated Jul 19, 2007, states conduct a risk analysis which includes(b)(4). However, your fnm did not conduct these activities for your LiteSaber 10 mm Handpiece nor your StarLite Fiber Optic devices.

Your firm’s response should be sent via e-mail to: US Food and Drug Administration, Division 3/West, Office of Medical Device and Radiological Health Operations atORADevices3FirmResponse@fda.hhs.gov. Please identify your response with FEI 3012547534. If you have any questions about the contents of this letter, please contact Compliance Officer Jeff R. Wooley at 214-253-5251, or via e-mail atJeffrey.wooley@fda.hhs.gov

Regulatory Context

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received your response dated December 22, 2017, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued on December 14, 2017. We address the response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

a.  Your firm did not document CAPAs(b)(4)or(b)(4)on your Corrective Action Form. Additionally, the records documenting these CAPAs did not include a root cause analysis or investigation details, as required by your CAPA procedure.

b.  Your Corrective Action Forms for CAPAs(b)(4)and(b)(4)do not include the complete specific corrective actions or documents associated with the corrections and do not include methods for verifying the effectiveness of those corrective actions.