WARNING LETTER
Avertix Medical, Inc.
MARCS-CMS 711080 —
September 03, 2025
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Timothy P. Moran
Recipient Title
President and CEO
Avertix Medical, Inc.
40 Christopher Way, Ste 201
Eatontown
,
NJ
07724
United States
tmoran@avertix.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
CMS # 711080
September 3, 2025
Dear Mr. Moran:
During an inspection of your firm located in Eatontown, NJ from February 19, 2025, through March 11, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures The Guardian System, an implantable coronary syndrome event detector. The Guardian System consists of three main system components: an implantable device used to monitor a patient’s electrogram (IMD); a hand-held telemetry device that provides alarms and alerts and interfaces between the IMD and programmer (EXD); and a programmer utilized by healthcare professionals to program the IMD and alarm/alert settings and retrieve and review IMD data (Programmer). 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.
Quality System Regulation Violations
This inspection revealed that these 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 received responses from David Keenan, Chief Technology Officer, dated March 31, 2025, and June 20, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to maintain complaint files; and failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a). Specifically, the firm’s procedure, Complaint Procedure, #1716-002, Rev Q (dated February 25, 2022) to Rev R (dated April 11, 2022) has not been adequately established in that:
a. Your firm failed to adequately maintain complaint files, as required by 21 CFR 820.198(a).
Specifically, section 5.1.2 of your complaint procedure requires all employees to report any product complaint or feedback from the field. Section 5.1.3 of the complaint procedure covers the review of “ISSUES” to disposition them as a “COMPLAINT” or “REJCT/No ACTION REQUIRED”. The FDA investigator identified 11 issues which meet the definition of a complaint and were not dispositioned as a complaint as required by your procedure. For example:
i.
(b)(4)
, reported on November 6, 2023, listing the patient effect description as “Guardian Device was removed from the patient due to a recurrent pocket infection post implant.”
ii.
(b)(4)
, reported on March 4, 2022, listed the programmer battery connector broke when trying to remove the battery.
iii.
(b)(4)
, reported on September 6, 2023, listed the USB Drive for Programmer was not connected and required formatting each time to use.
Additionally, six of eleven “nonconforming material reports” (NCMRs) reviewed during the inspection that met the definition of complaints were not considered complaints and as such were handled according to your nonconforming material process. For example:
iv.
(b)(4)
, created April 30, 2024, states that a Programmer (PROG-003) was returned from the field due to issues with the battery charging indicator light.
v.
(b)(4)
, created September 6, 2023, states a USB flash drive was not functioning properly in the field and was returned.
vi.
(b)(4)
, created November 22, 2022, states that a field clinical engineer reported that a Programmer Battery was damaged while being inserted into the Programmer.
The above “issues” and “nonconforming product reports” were not evaluated for MDR reportability and were not reviewed to determine if an investigation is necessary, since they were not considered complaints.
b. Your firm failed to adequately establish and maintain procedures to ensure that all complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198(a)(1).
Specifically, your firm’s
Complaint Procedure
, #1716-002, does not include a requirement for timely and uniform complaint handling. For example, the following complaints were entered as issues and were not escalated to complaints in a timely manner:
i. Complaint-00077: On July 17, 2024, your firm became aware of a reported issue where the physician was unable to retrieve data from the IMD implant. The complaint record was not opened until September 5, 2024 (50 days after becoming aware).
ii. Complaint-00066: On February 13, 2024, your firm became aware of an IMD explant due to an infection. The complaint record was not opened until March 28, 2024 (44 days after becoming aware).
iii. Complaint-00059: On November 30, 2023, your firm became aware of a reported “flat line IMD” event. The complaint record was not opened until January 5, 2024 (36 days after becoming aware).
iv. Complaint-00039: On October 28, 2022, your firm became aware of an IMD explant due to an infection. The complaint record was not opened until December 1, 2022 (34 days after becoming aware).
c. Your firm failed to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820 820.198(c).
Specifically, Section 5.1.4 of your
Complaint Procedure
requires investigation of complaints. Your firm failed to adequately review, evaluate, and investigate the following complaints that reported patient infection and subsequent explant of the implantable cardiac monitoring device (IMD), the implantable portion of The Guardian System:
i.
(b)(4)
, reported on February 13, 2024, that subsequently became Complaint-00066, documents the justification for not performing an investigation as: “
Physician determined patient had a pocket infection and made the decision to explant and device. No investigation needed
.”
ii.
(b)(4)
, reported on October 28, 2022, that subsequently became Complaint-00039, documents the “Initiate Investigation Process” option was selected but no investigation was performed and the “
Review for Closure
” section of the complaint records lists “
no investigation needed
.”
We reviewed your firm’s responses and conclude that they are not adequate. In the response, your firm states that CAPA 00015 was opened to capture all corrective and preventive work performed in relation to this observation. As part of CAPA 00015, your firm promised to
(b)(4)
. Your firm also promised to
(b)(4)
. However, the response does not address performing a retrospective review of all issues and nonconforming product reports to determine if other complaints exist and if investigations need to be performed. Several of the items promised by your firm continue to be in-progress (including but not limited to
(b)(4)
.
2. Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented, as required by 21 CFR 820.90(a).
Specifically, your
Nonconformance Material Procedure
, #1707-002, does not include a provision for the determination of the need for an investigation. For example, the following two nonconformances did not include a documented investigation or evaluation:
a.
(b)(4)
was created on June 27, 2024, for IMD batteries that were sent to your contract manufacturer for use in production were returned due to nonconformances (bent prongs). The disposition of the batteries was recorded as being scrapped. However, there was no investigation conducted into the cause of the bent probes and the nonconformance record does not include a rationale for not investigating.
b.
(b)(4)
was created on June 7, 2023, for the EXD-001 Battery Packaging Label (p/n
(b)(4)
) on the EXD-001 Battery, 10 Packs (p/n
(b)(4)
) listing an incorrect expiration date and battery lot code in finished goods inventory. Your firm reworked the nonconforming product. However, there was no investigation conducted into the cause of the incorrect labeling and the nonconformance record does not include a rationale for not investigating.
We reviewed your firm’s responses and conclude that they are not adequate. Your response promises to
(b)(4)
as well as plans to
(b)(4)
. All activities are captured in CAPA 00017 and all work is promised by
(b)(4)
. However, your response fails to address if a retrospective review of NCMRs will be conducted. Several of these promised actions (including CAPA 00017) remain in-progress with a tentative CAPA Effectiveness Verification planned due date of
(b)(4)
.
3. Failure to adequately establish and maintain procedures for validating the device design to include adequate risk analysis, as required by 21 CFR 820.30(g). Specifically, section 6.14 of your
Risk Management Procedure
, #1701-011, covers the information collection, information review, and actions related to the use of the Corrective and Preventive Action System and the Complaint System to monitor the device in the clinical and post-production phase to determine if reassessment of risks and/or assessment of new risks is necessary. Your firm failed to reassess the risk when estimated risks from a hazard differed from the actual risk observed in post-market CAPA and complaint data. For example:
a. Your firm has received three complaints of infection with the IMD portion of the Guardian System out of a total of
(b)(4)
IMDs implanted as of February 25, 2025. The observed rate of infection is
(b)(4)
%. In your device risk file,
Guardian System Risk Assessment
– P18, #0201-0200-001#P18, Rev B, dated November 13, 2023, the rate of infection was estimated to be
(b)(4)
%. The risk was not reassessed.
b. Your firm has received 24 complaints of battery failure due to electrical short before the device reached its expected service life of 6 years, causing patients to opt for early explant and/or replacement. The observed rate of battery failure is
(b)(4)
%. In your device risk file,
IMD AMSG3-E Hardware FMECA Report – P16
, #0212-0201-001#P16, Rev A; dated February 24, 2015, the rate of battery failure was estimated to be
(b)(4)
%. Further, your firm initiated CAPA-00012 in response to the battery failures. The “Process Impacts” section of this CAPA indicates that no updates to risk management were needed. The risk was not reassessed.
We reviewed your firm’s responses and conclude that they are not adequate. In the response, your firm indicates that CAPA 00016 was opened to address any corrective and preventive work taken as result of the observation including to assess the risk associated with infection using current performance data against historical data and to address the need to perform risk reviews on a regularly scheduled basis to keep the risk data current by July 1, 2025. However, your firm did not indicate if you intend to review, and update as necessary, the risk file utilizing post-market data for items other than risk of infection. Several of the items promised by your firm continue to be in-progress, including but not limited to
(b)(4)
which has a
(b)(4)
planned due date of
(b)(4)
.
4. Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm failed to follow your procedure, Corrective and Preventive Action Procedure, #1708-001, Rev J, dated October 23, 2020, when taking corrective and preventive actions. Two examples of lack of CAPA procedure implementation are as follows:
a. Your firm failed to follow your CAPA process for a corrective action taken as a result of a consumer complaint which led to a revision made to manufacturing procedure Process Specification, PROG-004 Final Shipping Manufacturing, #0217-1200-020#P18, Rev F, dated November 19, 2024. These actions were taken outside of the CAPA system and lack a documented CAPA investigation as well as verification of implementation and effectiveness.
b. Your firm failed to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). Specifically, section 5.9 of the Corrective and Preventive Action Procedure, #1708-001, Rev J, dated October 23, 2020, describes your firm’s process for establishing verification of effectiveness plans with predetermined criteria that verify if corrective and/or preventive actions were effective. Additionally, section 5.10 of the Corrective and Preventive Action Procedure, #1708-001, Rev J, dated October 23, 2020, describes the process for conducting the verification of effectiveness (VOE) phase to demonstrate effectiveness.
Review of five CAPAs closed between January 2022 and the time of the current inspection disclosed that four CAPAs (CAPA-00007, CAPA-00008, CAPA-00010, and CAPA-00014) lacked evidence that your firm verified or validated that the action taken was effective.
For example, CAPA-00007, was opened as a result of the previous inspection on March 15, 2022, related to a complaint involving EXD batteries having expired shelf life. Your firm implemented several corrective actions to correct the issue which were documented utilizing the complaint record (complaint number 00013) instead of through the CAPA system. CAPA-00007 was closed on March 31, 2022, without verifying the effectiveness of the correction and preventive actions taken.
We reviewed your firm’s responses and conclude that they are not adequate. In this response, your firm opened CAPA 00016 to document actions taken for this observation. Your firm promises to
(b)(4)
. For the 5 CAPAs lacking VOE plans and reports, your firm asks our Agency if
(b)(4)
(2021 or earlier). The decision to
(b)(4)
remains your firm’s decision as long as it is based on a rationale you determine to be appropriate given the 21 CFR 820.100(a)(4) and your own procedural requirement to demonstrate effectiveness of a CAPA action. You are also going to
(b)(4)
. Your response does not address if other CAPAs will be reviewed to determine if
(b)(4)
. Several of the items promised by your firm continue to be in-progress (including but not limited to
(b)(4)
.
5. Failure to validate with a high degree of assurance and approve according to established procedures, a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). Specifically, your firm’s Process Validation Procedure, #1705-002, Rev E, dated October 23, 2020, and Process Qualification Procedure, #1705-001, Rev F, dated October 23, 2020, were not adequately established in that both procedures fail to address sterilization validation. Your firm’s implantable cardiac monitoring device (IMD) undergoes
(b)(4)
sterilization. Further, the two procedures fail to document the process of requalification and revalidation (if necessary) of the sterilization cycle.
For example, the
(b)(4)
sterilization process for your firm’s IMD was last performed in June 2022 by a 3rd party in accordance with FDA-recognized standard ANSI/AAMI/ISO 11135:2014. Your firm has not reviewed the
(b)(4)
sterilization process since the 2022 requalification.
We reviewed your firm’s responses and conclude that they are not adequate. In the responses, you indicate that CAPA 00019 was opened as a result of the observation and that your firm promises to
(b)(4)
. However, your responses do not address if your firm’s plans to revise your process validation procedures to include sterilization. Additionally, supporting evidence (including CAPA 00019) of these promised actions remain in progress with a CAPA Effectiveness Verification planned due date for CAPA 00019 of
(b)(4)
.
6. Failure to adequately establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your
Supplier Management Procedure
(#1703-003), has not been fully implemented. For example:
a. Your firm’s
Supplier Management Procedure
(#1703-003) describes a process for supplier evaluation and acceptance using a supplier evaluation form. The Supplier Evaluation Form for the IMD battery supplier, (dated February 13, 2020), indicated your firm’s contract manufacturer would perform receiving inspections of these batteries and provide
(b)(4)
to Avertix. Your QA/QC manager stated these
(b)(4)
were not completed.
b. Your firm failed to adequately establish and maintain records of acceptable suppliers, contractors, and consultants, as required by 21 CFR 820.50(a)(3). Specifically, section 7.1.12 of Supplier Management Procedure, Rev K, states that “Quality Assurance is responsible for revising the Approved Supplier List with changes made based on acceptance/rejection of potential suppliers/re-evaluated suppliers/deactivated suppliers…” A software supplier used by your firm since 2023 to meet the requirements of the Medical Device Tracking regulation was not listed on your Approved Supplier List (Rev L, dated June 15, 2023).
We reviewed your firm’s responses and conclude that they are not adequate. In the responses, your firm promises and provided revisions to your Supplier Management Procedure (Document 1703-003) removing the requirement for
(b)(4)
for your contract manufacturer and to evidence of a new supplier evaluation for the software supplier utilized for medical device tracking by July 1, 2025. The responses do not indicate if other supplier evaluations will be evaluated and updated, as needed. Further, CAPA 00023 remains in progress with a CAPA Effectiveness Verification planned due date of December 1, 2025.
Medical Device Reporting (MDR) Violations
Our inspection also revealed that your firm’s Guardian System devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i. 21 CFR Part 803 - Medical Device Reporting was promulgated under section 519 of the Act, among other provisions. Significant violations include, but are not limited to, the following:
1. Failure to report to the FDA the information required by 21 CFR 803.52 in accordance with the requirements of 21 CFR 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
For example, the information included for Complaint-00066, Issue-00091, and Complaint-00039 reasonably suggests that each patient sustained an injury or illness (i.e., infection) following implantation of your firm’s Guardian System. These infections constituted serious injuries within the meaning of 21 CFR 803.3(w) because they necessitated surgical intervention (i.e., explantation) to preclude permanent impairment of a body function or permanent damage to a body structure. Your firm became aware of information that reasonably suggests that the Guardian System may have caused or contributed to a serious injury on February 13, 2024, for Complaint-00066, on November 6, 2023, for Issue-00091, and on October 28, 2022, for Complaint-00039. As such, Complaint-00066, Issue-00091, and Complaint-00039 represent MDR reportable events, as defined in 21 CFR 803.3(o)(2)(i). However, the FDA did not receive an MDR for each referenced event until April 10, 2025, which exceeded the required 30 calendar day reporting timeframe.
The adequacy of your firm’s responses cannot be determined at this time. We acknowledge that the FDA received the manufacturer reports, submitted using the electronic equivalent of Form 3500A, for the referenced serious injury events after the 30 calendar day reporting timeframe had elapsed. However, although the response referenced the updated MDR procedure “Medical Device Vigilance Procedures,” Document No. 1716-005, as part of its correction action for the late reporting issue, a copy of the updated MDR procedure was not included.
2. Failure to report to the FDA the information required by 21 CFR 803.52 in accordance with the requirements of 21 CFR 803.12(a), no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
For example, the information included for Complaints No. 00057, 00065, 00070, 00071, 00072, 00074, 00077, 00079, 00080, 00082, 00083, and 00086, reasonably suggests that your firm’s Guardian System malfunctioned while in use. Specifically, the device prematurely reached its end of service due to early battery depletion, meaning that it failed to meet its performance specifications or otherwise perform as intended under 21 CFR 803.3(k). Your firm initiated recall Z-1140-2025 for the referenced malfunction. A malfunction is reportable if the manufacturer takes or would be required to take an action under sections 518 or 519(g) of the Act as a result of the malfunction of the device or other similar devices. See Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration, 60 Fed. Reg. 63585 (Dec. 11, 1995) (referring to section 519(f), which has since been redesignated as section 519(g)). As such, the referenced complaints represent MDR reportable events, as defined under 21 CFR 803.3(o)(2)(ii).
Your firm became aware of information on the following dates that reasonably suggests that the Guardian System had malfunctioned and this device or a similar device your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur: October 10, 2023, for Complaint No. 00057; February 26, 2024, for 00065; May 28, 2024, for 00070; May 14, 2024, for 00071; May 5, 2024, for 00072; May 14, 2024, for 00074; July 17, 2024, for 00077; August 29, 2024, for 00079; August 21, 2024, for 00080; November 19, 2024, for 0008; November 19, 2024, for 00083; and December 3, 2024, for 00086. Your firm submitted a report for each event using the MedWatch Online Voluntary Reporting Form. Specifically, MW5149541 (Complaint No. 00057), MW5153561 (Complaint No. 00065), MW5159171 (Complaint No. 00070), MW5159172 (Complaint No.00071), MW5159173 (Complaint No. 00072), MW5159805 (Complaint No. 00074), MW5160629 (Complaint No. 00077), MW5160632 (Complaint No. 00079), MW5160633 (Complaint No. 00080), MW5164478 (Complaint No. 00082), MW5164476 (Complaint No. 00083), and MW5164481 (Complaint No. 00086). The submission of reports using the voluntary MedWatch Online Voluntary Reporting Form does not fulfill reporting obligations arising under 21 CFR Part 803. An electronic submission of a mandatory report from a manufacturer must contain the information from the applicable blocks of Form FDA 3500A. All medical device reports must be submitted within the required timeframes. However, the FDA did not receive the corresponding MDRs until April 14, 2025, which exceeded the required 30 calendar day reporting timeframe.
The adequacy of your firm’s responses cannot be determined at this time. We acknowledge that the FDA received the manufacturer reports, submitted using the electronic equivalent of Form 3500A, for the referenced malfunction events based on your firm’s retrospective review on April 14, 2025, after the 30 calendar day reporting timeframe had elapsed.
However, although the response referenced the updated MDR procedure “Medical Device Vigilance Procedures,” Document No. 1716-005, as part of its correction action for the late reporting issue, a copy of the updated MDR procedure was not included.
In addition, the inspection revealed that your firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, your firm presented the document titled “Medical Device Vigilance Procedures,” Document No. 1716-005, Rev. F, dated June 25, 2024, as its MDR procedure. Upon review, we conclude that the MDR procedure does not develop, maintain, and implement written MDR procedures for internal systems that provide for timely transmission of complete medical device reports to FDA, as required by 21 CFR 803.17(a)(3). Specifically, the procedure 1716-005, Rev. F does not include instructions for how your firm will comply with the 21 CFR 803.12(a) requirement to submit reports to FDA in an electronic format that FDA can process, review, and archive. As a manufacturer, you must submit reports of individual adverse events to FDA in an electronic format in accordance with 21 CFR 803.12(a) and 803.20, unless granted an exemption under 21 CFR 803.19.
The adequacy of your firm’s responses cannot be determined at this time. While your response included a copy of the updated Complaint Procedure, Document No.1716-002, and staff training records, it referenced an update to the MDR procedure “Medical Device Vigilance Procedures,” Document No. 1716-005, without including a copy. Without the referenced document, we cannot fully assess the adequacy of the response.
Corrections and Removals Violation
Our inspection also revealed that your firm’s Guardian System Model AMSG3‐E IMD implant devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i. 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals was promulgated under section 519 of the Act, among other provisions. Violations include, but are not limited to, the following:
Failure to submit to the FDA within 10 working days of initiating a correction or removal a report required by 21 CFR 806.10.
Specifically, on September 18, 2023, Avertix Medical, Inc., delivered a letter to physicians who have patients implanted with a Model AMSG3‐E IMD manufactured during the period when a contamination issue was occurring on the battery production line. This issue led to premature battery depletion in the Guardian System implants, which can result in failure to monitor and earlier‐than‐expected implant replacement surgery. The letter recommends reducing the interval of regular follow-up visits and reinforcing the patient training. FDA determined that shorter device implant life leading to sooner than expected replacement surgery may present a risk to health. This action constitutes a medical device correction or removal initiated to reduce a risk to health posed by the device or remedy a violation of the Act caused by the device which may present a risk to health under 21 CFR 806.10(a). Accordingly, you were required to submit a Report of Correction or Removal to FDA within 10 working days of initiation, under 21 CFR 806.10(b). You submitted a Medical Device Report of Correction or Removal to FDA for this action on December 11, 2024.
We reviewed your firm’s responses and conclude that they are not adequate. The responses do not contain evidence that your firm’s procedures will result in compliance with the medical device correction and removal reporting requirements in 21 CFR 806. CAPA 00020 states that management failed to recognize that it needed to submit a Report of Correction or Removal within 10 working days of initiation. Your corrective action was retraining personnel in two procedures, Complaint Procedure (1716-002) and Vigilance Procedure (1716-005). You stated that your Quality Management System (QMS) procedure specifies that recalls or corrections must be reported within 10 days. However, your responses did not include a new revision of 1716-005 nor procedure 1716-004, PRODUCT RECALLS, CORRECTIONS AND REMOVALS. Procedure 1716-004 Rev F, collected in the inspection, notes that the Recall Coordinator is responsible for communicating with regulatory agencies within defined reporting times as per the Vigilance procedure. The procedure titled MEDICAL DEVICE VIGILANCE PROCEDURES, 1716-005 Rev F, collected during the inspection, does not describe Reports of Corrections or Removals, required by 21 CFR 806. Therefore, training personnel on 1716-005 will not help personnel know the timeframe for reporting a Medical Device Correction or Removal to FDA.
Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter 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.
Other federal agencies may take your compliance with the Act and its implementing regulations into account when considering the award of federal 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 addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.
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 address 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 should 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 any violations included in this Warning Letter. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent via email to Establishment Assessment Team 1 Assistant Director Gina Brackett at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 711080” when replying. If you have any questions about the contents of this letter, please contact: Sean Moynihan, Compliance Officer at sean.moynihan@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility or associated with your firm’s devices. 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 any violations and take prompt actions to address any violations and bring the products into compliance.
Sincerely,
/S/
Matthew G. Hillebrenner
Deputy Director
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
03/17/2026
Regulated Product(s)
Medical Devices