Fda Innova Medical Group Warning Letter 614819 2021 06 10

Summary

An FDA Warning Letter, MARCS-CMS 614819, dated June 10, 2021, to Daniel J. Elliot, Chief Executive Officer of Innova Medical Group, Inc., after inspections from March 15 through April 9, 2021. The letter states that the SARS-CoV-2 Antigen Rapid Qualitative Test was distributed in the United States without FDA approval, clearance or authorization, making it adulterated under section 501(f)(1)(B) and misbranded under section 502(o), and that labeling claims for the 25T Configuration (sensitivity 96%, specificity 100%) and the 7T Configuration (positive percent agreement 81.4%) were false or misleading under section 502(a). It notes that clinical data in the firm's EUA request was identical to data provided by other manufacturers, lists quality system and medical device reporting violations, and demands responses within 48 hours and fifteen business days.

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# Innova Medical Group, Inc. — FDA Warning Letter (MARCS-CMS 614819) — June 10, 2021

**Delivery Method:** VIA Electronic Mail
**Product:** Medical Devices
**Recipient:** Daniel J. Elliot, Chief Executive Officer, Innova Medical Group, Inc.
**Address:** 800 E. Colorado Blvd., Suite 288, Pasadena, CA 91101, United States
**Issuing Office:** Center for Devices and Radiological Health
**CMS #:** 614819

June 10, 2021

Dear Mr. Elliot:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm's medical device operations, Innova Medical Group, Inc., located at 800 E. Colorado Blvd., Suite 288, Pasadena, CA from March 15 through April 9, 2021. In addition, your other manufacturing facilities at 495 N. Berry Street, Brea, CA, and MPS Medical, Inc. at 785 Challenger Street, Brea, CA, were also inspected from March 15 through April 8, 2021. During these inspections, the FDA investigators determined that your firm is a medical device manufacturer and initial distributor/importer of the SARS-CoV-2 Antigen Rapid Qualitative Test (also distributed under the names INNOVA COVID-19 Self-Test Kit (3T Configuration), INNOVA SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and INNOVA SARS-CoV-2-Antigen Rapid Qualitative Test (25T Configuration)). Based on our review, your SARS-CoV-2 Antigen Rapid Qualitative Test is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people, and thus, it is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 321(h).

Our inspection revealed that the SARS-CoV-2 Antigen Rapid Qualitative Test has been distributed in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, the product is adulterated under section 501(f)(1)(B) of the Act... because your firm does not have an approved application for premarket approval (PMA)... or an approved application for an investigational device exemption... The product is also misbranded under section 502(o) of the Act... because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k)...

[HHS public health emergency / Presidential national emergency declarations recited. FDA requests immediate action to cease sale and distribution of unapproved, uncleared, and unauthorized products.]

## False or misleading labeling (§ 502(a))

Our inspections also revealed that the 25T Configuration and 7T Configuration of the SARS-CoV-2 Antigen Rapid Qualitative Test are misbranded within the meaning of section 502(a) of the Act, 21 U.S.C. § 352(a), in that the devices' respective labeling was false or misleading. More specifically, the labeling distributed for your 25T Configuration devices included a "Clinical Performance" section, which claimed a Relative Sensitivity of 96% (88.75-99.17% CI); a Relative Specificity of 100% (98.34-100% CI); and an Accuracy of 98.98% (97.06-99.79% CI). This level of clinical performance for the 25T Configuration devices appears unsupported by any clinical data including both clinical performance data submitted to FDA in your Emergency Use Authorization (EUA) request... and in published reports of clinical studies... Similarly, the labeling distributed for your 7T Configuration devices included a "Performance of Prospective Clinical Study" section based on a prospective clinical study conducted by "third-party investigators in UK in September and October 2020" which claimed a Positive Percent Agreement of 81.4% (74.3-88.4% CI). This PPA for the 7T Configuration devices does not appear to align with the PPA observed in the phase 3b prospective clinical study conducted in the United Kingdom. Accordingly, the clinical performance estimates reported in the labeling of the 25T Configuration and 7T Configurations devices are false or misleading as they do not accurately reflect the performance estimates observed during the clinical studies of your devices.

**Separate and apart from the foregoing issues, FDA further notes that the clinical study data you submitted in your EUA request for the SARS-CoV-2 Antigen Rapid Qualitative Test was identical to data previously provided by other manufacturers in their separate EUA requests.** The data reliability and accuracy issues noted herein raise significant concerns that the performance of the SARS-CoV-2 Antigen Rapid Qualitative Test has not been adequately established, and that the products distributed by Innova without FDA approval, clearance, or authorization could present a serious risk to the public health.

## Quality System (21 CFR Part 820) violations

The inspections also revealed the device is adulterated within the meaning of section 501(h)... FDA received Innova's responses dated April 30, 2021 (Eric Grubel, COO) and May 28, 2021 (Janet L. Michener Whipple, Interim VP of Quality) responding to the Form FDA 483 issued April 9, 2021. Violations include, but are not limited to:

1. **Failure to establish procedures for control and distribution of finished devices (21 CFR § 820.160(a)).** Innova executed contractual agreements with at least [(b)(4)] distributors and distributed more than [(b)(4)] test kits to US customers (Indiana, New York, Vermont, Oregon during Jan–Feb 2021). No records demonstrated devices were approved for release. (CAPA #2021-002 — adequacy cannot be determined.)
2. **Failure to establish procedures for acceptance activities (21 CFR § 820.80(a)).** Test kits were not inspected, tested, or verified after receipt from the contract manufacturer in China or prior to shipment; 7T and 3T boxes shipped with incorrect Instructions for Use. (CAPA #2021-003.)
3. **Failure to establish procedures to control nonconforming product (21 CFR § 820.90(a)).** Investigators observed 13 cartons of tests co-mingled in a storage room with returned nonconforming kits, evaluation samples, and damaged controls slated for destruction; not identified as nonconforming. (CAPA #2021-004.)
4. **Failure to establish CAPA procedures (21 CFR § 820.100(a)).** (CAPA #2021-001.)
5. **Failure to establish complaint-handling procedures (21 CFR § 820.198(a)).** Response did not indicate whether a retrospective review of prior complaints would occur; storage room held damaged product returned from customers. (CAPA #2021-006.)
6. **Failure to establish supplier evaluation procedures (21 CFR § 820.50).** Innova did not evaluate its only contract manufacturer of the test system. (CAPA #2021-005.)

## Medical Device Reporting (MDR) violations (§ 502(t)(2))

7. **Failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17).** Innova's April 30, 2021 response was found not adequate; the MDR procedure (Document 7.0, Rev 1.0, eff. 4/29/2021) does not reference a process for identifying and evaluating events involving similar devices marketed in the U.S., as potentially reportable under 21 CFR 803.50 and 803.53.

## Response deadlines

**Within 48 hours**, email COVID-19-Task-Force-CDRH@fda.hhs.gov describing steps taken to address the distribution violations. Notify FDA **within fifteen business days** of steps taken to correct the Quality Systems and MDR reporting violations. Innova will be added to FDA's published list of firms that received warning letters concerning COVID-19 related products. Failure to address violations may result in legal action including seizure and injunction.

Sincerely,
/S/ Timothy T. Stenzel, M.D., Ph.D., Director, OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality, CDRH
/S/ Shari J. Shambaugh, Program Division Director, Office of Medical Device and Radiological Health, Division 3
Cc: Mr. Eric E. Grubel, COO

**Content current as of:** 06/10/2021
**Regulated Product(s):** Medical Devices

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