WARNING LETTER
BioModeling Solutions, Inc.
MARCS-CMS 540821 —
January 12, 2018
Recipient:
Recipient Name
Gurdev Dave Singh, DDSC PhD DMD
BioModeling Solutions, Inc.
1915 NW Amberglen Pkwy, Suite 400
Beaverton
,
OR
97006
United States
Issuing Office:
Los Angeles District Office
United States
Office of Medical Device and Radiological Health Operations
Division 3 West
19701 Fairchild
Irvine, CA 92612
WARNING LETTER
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
January 12, 2018
WL # 540821-18
Gurdev Dave Singh, DDSC PhD DMD, President
BioModeling Solutions, Inc.
1915 NW Amberglen Pkwy, Suite 400
Beaverton, OR 97006
Dear Dr. Singh:
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.
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).
Specifically, your firm initiated a change in the design of the mRNA device between February 2015 and October 2015. You did not document verification or validation of the design change. During the inspection, you were found to lack procedures for Design Control. You provided a copy of the procedure
(b)(4)
#820.30, 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 implementation of the procedure.
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.
3) Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a).
Specifically, we reviewed a complaint dated 04/04/2017 describing soreness or pain to chew with the DNA device. During the inspection, you were found to lack procedures for complaint handling. You provided a copy of the procedure
(b)(4)
#820.198, 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 implementation of the procedure.
4) Failure to establish document co ntrol procedures as required by 21 CFR 820.40.
Specifically, your firm lacks writt en procedures for document control. Your instructional document,
(b)(4)
provided to dental laboratories for the manufacture of your DNA and mRNA devices was not reviewed and approved.
5) Failure to establish procedures for ident ifying training needs as required by 21 CFR 820.25(b).
Specifically, your firm lacks written training procedures.
Our inspection also revealed that the device is misbranded within the meaning of section 502(t)(2) of the Act [21 U.S.C. § 352(t)(2)] in that your firm fai led or refused to furn ish material or information respecting the device that is required by or under section 519 of the Act [21 U.S.C. § 360i] and 21 CFR 803 - Medical Device Reporting (MOR) regulation.
These violations include, but are not limited to, the following:
Failure to develop and maintain written MOR procedures for internal systems as required by 21 CFR 803.17.
Specifically, your firm has not developed or maintained written MOR procedures for internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MOR requirements.
In addition, we reviewed your Daytime Nighttime Appliance (DNA) and mandibular Repositioning Nighttime Appliance (mRNA) devices. We have identified several concerns with these devices as they relate, but not limited, to the following: promotional and advertising claims; intended use and device modifications; 510(k); and registration/listing. We would like to meet with you to discuss these issues. Please contact Compliance Officer Dr. Raymond W. Brullo by phone at 949-608-2918 or by email to
raymond.brullo@fda.hhs.gov
on or before January 19, 2018 to schedule this meeting. Information provided during the meeting will be taken into consideration with any response(s) and may result in additional comments.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from reoccurring. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your firm's response to this letter should be sent to the following email address:
oradevices3firmresponse@fda.hhs.gov
Refer to CMS case# 540821 when replying. If you have any questions about the content of this letter please contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918 or via e-mail at
raymond.brullo@fda.hhs.gov
.
Sincerely,
/S/
Shari J. Shambaugh
Acting Program Division Director
Content current as of:
01/23/2018