BioModeling Solutions, Inc. FDA Warning (2018)
Compiled by the Supplement Safety Data Team | Sourced from Official FDA Records on January 12, 2018
Executive Summary
The FDA issued a warning letter to BioModeling Solutions, Inc. on January 12, 2018 citing misbranding, adulteration, cgmp violations. The letter was issued by Los Angeles District Office.
Detailed Analysis
False Claims and Regulatory Violations
During an inspection of your firm located in Beaverton, Oregon from August 21, 2017 through September 11, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures and distributes Class I and II dental medical devices promoted for uses in nighttime snoring and Obstructive Sleep Apnea (OSA). 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.
2) Failure to establish and maintain procedures for correct ive and preventive action (CAPA), as required by 21 CFR 820.100(a).
Specifically, you identified a corrective action change in the design of the mRNA device to increase its strength to prevent breakage. During the inspection, you were found to lack procedures for CAPA. You provided a copy of the procedure(b)(4)#820.100, dated 09/11/2017. However, due to a lack of a written response to this Observation after the inspection, we are unable to assess the adequacy of implementat ion of the procedure.
Potential Health Risks
Office of Medical Device and Radiological Health OperationsDivision 3 West19701 FairchildIrvine, CA 92612
Regulatory Context
This inspection revealed that your 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 did not receive a response from your firm to our investigator's observations noted on the Form FDA 483, List of lnspectional Observations, that was issued to your firm on September 11, 2017. The violations include, but are not limited to, the following:
1) Failure to establish procedures for design control, as required by 21 CFR 820.30(a).
Key Entities Identified
Frequently Asked Questions
- What did the FDA find wrong with BioModeling Solutions, Inc.?
- The FDA issued a warning letter citing misbranding, adulteration related to their products or manufacturing practices.
- Are BioModeling Solutions, Inc. products safe to use?
- Based on the FDA's findings, consumers should exercise caution. The company was found to have misbranding that may affect product safety.
- What should I do if I've used BioModeling Solutions, Inc. products?
- If you have used products from BioModeling Solutions, Inc. and experience any adverse effects, contact your healthcare provider immediately. You can also report adverse events to the FDA's MedWatch program.
Source Document
This report is based on an official FDA warning letter. The original document is a public record.
View Original FDA Warning Letter