FDA WARNING_LETTER - BioModeling Solutions, Inc. - September 11, 2017

The FDA issued a Warning Letter to BioModeling Solutions, Inc. following an inspection from August 21 to September 11, 2017, which found their Class I and II dental medical devices (for snoring and Obstructive Sleep Apnea) to be adulterated. The firm failed to conform with Quality System regulation (21 CFR Part 820) and did not respond to the FDA 483 observations.

Violations include: 1. Failure to establish design control procedures (21 CFR 820.30(a)), specifically lacking documentation for a design change to the mRNA device. 2. Failure to establish corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), evidenced by an undocumented design change to increase mRNA device strength. 3. Failure to establish complaint handling procedures (21 CFR 820.198(a)), as seen with an unaddressed complaint regarding the DNA device. 4. Failure to establish document control procedures (21 CFR 820.40), with instructional documents for DNA and mRNA devices not being reviewed or approved. 5. Failure to establish training needs procedures (21 CFR 820.25(b)).

Additionally, the devices are misbranded (section 502(t)(2) of the Act) due to the firm'