- Delivery Method:
- VIA Electronic Mail
- Medical Devices
Recipient NameAlan R. Carver
- DeChoker LLC
4880 Van Gordon St., Suite 200
Wheat Ridge, CO 80033
- Issuing Office:
- Office of Medical Device and Radiological Health, Division 3
May 10, 2021
Dear Mr. Carver:
The United States Food and Drug Administration (FDA) conducted inspection of your medical device operations at 4880 Van Gordon St., Suite 200, Wheat Ridge, CO 80033 from February 17, 2021 to February 26, 2021, an Investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the “Dechoker” tracheobronchial suction device. 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 function of the body. In addition, tracheobronchial suction catheters are classified under 21 Code of Federal Regulations (CFR) 868.6810. Devices classified under 21 CFR 868.6810 are subject to Design Controls 21 CFR 820.30 per 820.30(a)(2).
This inspection revealed that the Dechoker device is 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 responses dated March 19, 2021 and April 19, 2021 concerning our Investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued on February 26, 2021. We address the responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).
Specifically, your firm has manufactured and distributed (b)(4) Dechoker devices intended to remove an acute obstruction of a choking victim since May 2019, yet you have not validated the (b)(4) processes used in the manufacturing of the devices.
We have reviewed your responses and determined they are inadequate. Your responses state your firm will hire a consultant to conduct the necessary validation of the (b)(4) process. However, you do not address systemic corrective actions or containment activities your firm will take. For example, your responses do not discuss review of other processes to confirm appropriate validations have been conducted. Your responses do not identify what actions your firm will take to ensure the effectiveness of the (b)(4) process used until the process validation has been completed. Your responses do not address product previously distributed that was manufactured using the unvalidated process.
2. Failure to establish and maintain adequate procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
Specifically, your firm has not adequately established your design control procedures documented in your standard operating procedures entitled “Product Realization Procedure”, SOP-014 Rev. D dated February 13, 2021 and “Product Realization Procedure”, SOP-014 Rev. C dated June 21, 2019.
a. Your firm has not established adequate design inputs for your Dechoker device as required by 21 CFR 820.30(c).
i. Your “Product Realization Procedure” does not include requirements for addressing ambiguous or conflicting inputs. Your “Adult Dechoker Class 1 Requirements Document For Models IDCH-01, IDCH-02, IDCH-03 (Toddler, Child and Adult)” dated February 16, 2021 documents design input “(b)(4)” with a peak suction of (b)(4). The previous revision of the document identifies the suction to be (b)(4). Your “Design FMEA, RSK-005” Rev. B dated October 1, 2019 documents the suction to be (b)(4). Your firm has not addressed these conflicting specifications.
ii. “Adult Dechoker Class 1 Requirements Document For Models IDCH-01, IDCH-02, IDCH-03 (Toddler, Child and Adult)” dated February 16, 2021 identifies the support for the (b)(4) specification to be “Reference Literature”. However, you could not provide these records during the inspection and your March 19, 2021 acknowledges this literature does not exist.
iii. Your device’s design inputs were not documented on “FRM-025” as required by Rev. C of your “Product Realization Procedure”.
b. Your firm has not established adequate design verification procedures for your Dechoker device, as required by 21 CFR 820.30(f).
i. Your firm’s design verification test report entitled “(b)(4)”, SOP DECH-031 Rev. A dated January 3, 2020 is inadequate. Your firm does not have records of the testing or supporting data. This testing was not conducted to an approved protocol and does not have defined and approved acceptance criteria.
ii. Your firm’s design verification test entitled “(b)(4) dated April 9, 2016 which was documented as a mitigation activity for (b)(4) in your Dechoker risk analysis records is inadequate. This verification report does not identify the (b)(4) tested or provide a valid statistical rationale for this sample size. Additionally, the report does not identify who conducted the testing or the date it was conducted.
c. Your firm has not conducted design validation on your Dechoker device, as required by 21 CFR 820.30(g).
i. You acknowledged your firm has not conducted design validation activities.
ii. Your firm’s “Risk Management Procedure”, SOP-008 Rev. C, dated February 12, 2021 requires previously unrecognized risks be input into the risk management process. Since October 2019, your firm has received 13 complaints for (b)(4) failures that have resulted in corrective and preventive actions being initiated. However, this failure mode is not identified in your “Design FMEA”, RSK-005 Rev. B, dated October 1, 2019 which was reviewed on February 16, 2021 by your firm.
iii. Your firm’s “Design FMEA”, RSK-005 Rev. B, dated October 1, 2019 which was reviewed on February 16, 2021 was not reviewed and evaluated per your firm’s “Rating Scales for Evaluation” described in Appendix 1 of “Your firm’s “Risk Management Procedure”, SOP-008 Rev. C, dated February 12, 2021. The values applied for severity and occurrence on your Design FEMA for every item are 8 and 10, respectively.
The adequacy of your responses cannot be determined at this time. Your responses state you have hired a design engineer who will review your design activities. However, you do not provide specific descriptions of your planned corrective actions. Additionally, your responses do not address how you evaluated previously manufactured devices or devices that are being manufactured until adequate design controls are established.
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
Specifically, Corrective and Preventive Action Procedure, SOP-005, Rev. C, dated February 16, 2021 (and previous revisions: B, dated 2/9/21; A, dated January 29, 2016) has not been adequately established as CAPA records do not include all required information such as documentation of implementation of corrective and preventive actions, investigation, objective evidence of corrective/preventive actions, and/or verification of effectiveness.
a. CAPA 2019-14 was opened on October 21, 2019 for damaged products related to (b)(4). Documentation of the investigation and scope of the problem is inadequate and there was no follow up on the Corrective and Preventive Action Form (CAPA), FRM-003. Your firm continues to see reports (at least 13 to date) of these or similar (b)(4) failures, yet there is no documentation of containment and/or corrective actions to this issue to date. Moreover, there is no documentation of required Executive Management authorization/sign off on this record.
b. CAPA 2019-15, was opened on Oct ober 16, 2019 to address a complaint reporting use of the Dechoker device that caused unspecified oropharynx injuries where patient ended up with pulmonary edema and (b)(4). There was no documentation of investigation, corrective and preventive action(s) (i.e. modify specification to (b)(4)) taken to address this issue. Also, there is no documentation of required Executive Management authorization/sign off on this record.
We have reviewed your responses and determined they are inadequate. Your responses identify your firm will revise your CAPA procedures and initiate a CAPA review board. However, you have not identified how you will correct the specific CAPAs identified on the FDA 483 or what containment activities will be taken until the identified corrective actions can be taken.
4. Failure to establish and maintain adequate procedures for acceptance activities, which include inspections, tests, or other verification activities, as required by 21 CFR 820.80(a).
Specifically, your “Receiving and Acceptance Activities Procedure”, SOP-012, Rev. C, dated February 13, 2021 (and previous revision B, dated August 3, 2019) have not been adequately established to ensure that specified requirements for in-process and/or final product are met.
For example, (b)(4) in Production of Dechoker Procedure, SOP-024, Rev. H, dated February 10, 2021, instructs the tester to (b)(4). There is no additional testing to ensure the suction of the device meets the specification(s) defined in the design documentation/risk analysis (i.e. (b)(4)). This test method does not provide results to show the indicated specification has been met and this test method has not been validated.
We have reviewed your responses and determined they are inadequate. Your responses state you will develop an appropriate test method for the (b)(4) test. However, your responses do not address how your firm will evaluate other acceptance activities to ensure compliance. Additionally, your responses do not address how you evaluated previously manufactured product that were manufactured using the inadequate acceptance testing and any containment activities to be taken until your corrective actions can be implemented.
5. Failure to establish and maintain adequate procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2).
Specifically, “Control of Nonconforming Product Procedure”, SOP-011, Rev. D, dated February 13, 2021 (and previous revision C, dated October 29, 2020; B, dated June 27, 2019) has not been adequately established as rework is not performed to documented instructions taking into account the potential adverse effect of the rework of the process. For example, your firm did not evaluate the potential adverse effect of the rework ((b)(4)) conducted to units in lots (b)(4), dated February 11, 2021; (b)(4), dated February 2, 2021; (b)(4), dated February 13, 2021; and (b)(4), dated February 13, 2021. Further, there was unclear and/or conflicting documentation of actual nonconformances and retesting of these units.
We have reviewed your responses and determined they are inadequate. Your responses state your firm will review your nonconforming product procedures. However, your responses do not address how it will review previously conducted rework for adequacy.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been corrected. Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. If you believe that your products are not in violation of the Act, please respond to FDA with your reasoning and any supporting information for our consideration.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Additionally, we request you contact Jeff Wooley, Compliance Officer at 214-253-5251 to arrange a time for a regulatory meeting (via teleconference) to discuss the violations in this letter and your ongoing corrective actions. In addition to the deficiencies identified above, we request you be prepared to discuss the following during our meeting:
1. Specific corrective actions and/or investigation conducted to address your firm’s identification of (b)(4) as potential contributing factors to MDR 3011422544-2021-00001.
2. How your firm assesses risk differences as they related to product design and manufacturing processes between your toddler, child, and adult models of the Dechoker device.
3. Current status and outcome of your retrospective Engineering Change Request (ECR) reviews described in your March 19, 2021 response to the FDA 483, Inspectional Observations.
Your response should be sent to: US Food and Drug Administration, Division 3/West, Office of Medical Device and Radiological Health Operations at ORADevices3FirmResponse@fda.hhs.gov. Please identify your response with FEI 3011422544.
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 at firstname.lastname@example.org.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological
Health, Division 3