WARNING LETTER
Criticare Technologies, Inc.
MARCS-CMS 686915 —
July 12, 2024
Delivery Method:
United Parcel Service
Product:
Medical Devices
Recipient:
Recipient Name
Neeraj Jha
Recipient Title
CEO
Criticare Technologies, Inc.
6901 TPC Drive, Suite 300
Orlando
,
FL
32822
United States
neeraj@criticare.com
Issuing Office:
Division of Medical Device and Radiological Health Operations East
United States
WARNING LETTER
CMS # 686915
July 12, 2024
Dear Mr. Jha:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Criticare Technologies, Inc., 333 Strawberry Field Rd Ste 11, Warwick, RI, FEI 3012238587, from March 21, 2024, through May 10, 2024. During the inspection, the FDA investigator determined that your firm is a manufacturer of patient monitors including the nGenuity patient vital signs monitor. 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 the above 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 your response dated June 3, 2023, from John Haefele, Vice President, and General Manager. which responded to the Form FDA 483, List of Inspectional Observations issued to your firm on May 10, 2024. We address your response below.
Your significant violations are as follows:
1. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Review of your firms Corrective and Preventive Action (CAPA) Procedure, CTI 221 rev H, revealed that it does not provide instructions in sufficient detail to; identify existing and potential causes of nonconforming product, or other quality problems; conduct investigations, identify, and take appropriate corrective or preventive actions, or verify that any such actions are effective. The below examples describe a CAPA system that does not meet the above requirements of 21 CFR.820.100(a):
Your firm opened CAPA 1098 on May 1, 2023, to address a nGenuity device shutting off intermittently. During the inspection, your Vice President indicated that since November 2019, your firm received 21 complaints related to these devices shutting off. One of these complaints (4932) references the device shutting off during surgery. CAPA 1098 did not include any investigation and was still open at the time of the inspection.
Your firm opened CAPA 1033 on December 1, 2017, and CAPA 1059 on July 17, 2018, to address CO2 module issues associated with your vital sign monitors. Since January 1, 2022, your firm has received 276 complaints related to the CO2 module of the nGenuity device, including reports of check line errors, CO2 measurements not reading/displaying, and distorted waveforms. CAPA 1033 did not include any investigation and the investigation in CAPA 1059 was not completed. Both CAPAs were open at the time of the inspection with the last notations dated June 1, 2021.
Your firm opened CAPA 1054 on July 17, 2018, to address SpO2 printed circuit boards assembly (PCBA) related issues with your vital sign monitors. Since January 1, 2022, your firm received 68 complaints related to the SpO2 module. CAPA 1054 did not include any investigation. This CAPA was still open at the time of the inspection with the last notation documented June 1, 2021.
Your firm opened two CAPAs, 1046 and 1050, on August 2, 2018, to address in-process nGenuity analog printed circuit boards (PCBs) and electrocardiogram (ECG) related issues. Since January 2022, your firm received 67 complaints related to the ECG module, including false flat lines or alerts of asystole and noisy waveforms. Both CAPAs were still open at the time of the inspection, and both indicated further investigation was needed with the last notations documented June 1, 2021.
Three CAPAs (1086, 1088, and 1090), related to purchasing, CAPAs, and acceptance activities, were all initiated on November 18, 2019, to address observations from the previous FDA inspection. All four were closed despite not having an adequate root cause investigation and no effectiveness check plan. Two CAPAs (1091 and 1094), were also opened on November 18, 2019, to address design and complaint issues from the previous inspection. Verification of the proposed corrective actions were not performed for either of these CAPAs and were still open at the time of the inspection with no activity since June 1, 2021. We observed continuing deficiencies in all these above quality systems (purchasing, CAPAs, acceptance activities, design and complaints), during our recent inspection.
This is a repeat deficiency from our 2017 Warning Letter.
We reviewed your firm’s response and concluded that it is not adequate. You have not provided sufficient details regarding any corrective actions, documents, or a timeline for completion to ensure these CAPA violations will be corrected at your facility.
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 controlled and documented the design of your nGenuity devices. For example:
Your firm has not adequately conducted a risk analysis for your nGenuity devices, as required by 21 CFR 820.30(g). Specifically, your firm provided a Hazard Analysis & Management document for your nGenuity CO2 Project, dated 2007, which was a document from the company you purchased in 2015. This did not identify risks associated with distorted displays or devices shutting down unexpectedly. Since 2016, your firm received 629 complaints related to distorted displays and at least 21 complaints related to monitors shutting down unexpectedly with your nGenuity device.
Also, the above 2007 Hazard Analysis & Management document for your nGenuity CO2 Project, did not identify any hazards related to faulty internal ECG cables, which were incorporated into certain nGenuity devices after 2015. During the inspection, your Vice President & General Manager stated that this section of the hazard analysis is incomplete, and a faulty internal ECG cable should be identified as another hazard.
Your firm has not adequately performed a design verification for your nGenuity device to confirm that the design output meets design input requirements, as required by 21 CFR 820.30(f). Specifically, the SpO2 accuracy specifications, in a document dated 2006, are defined as
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for the range of
(b)(4)
and
(b)(4)
for the range of
(b)(4)
. Two Pulse
(b)(4)
Reports from 2000 and 2001 were provided during the inspection to support the above accuracy claims. However, these reports do not support the claims made for the
(b)(4)
. For example, the reports did not include acceptance criteria, a rationale for the sample size of
(b)(4)
participants, and traceability for the devices reviewed. Your firm has been relying on older design documents for your nGenuity device yet have not performed a sufficient design review to confirm the current design has been verified.
Your firm has not adequately conducted design validation for your nGenuity devices as required by 21 CFR 820.30(g). Specifically, the 8100E Series
(b)(4)
provided during the inspection did not include acceptance criteria and did not document a rationale for the sample size of
(b)(4)
collecting
(b)(4)
on
(b)(4)
participants. Your firm has been relying on older design documents for your nGenuity device yet have not performed a sufficient design review to confirm the current device design has been validated.
We reviewed your firm’s response and concluded that it is not adequate. You have not provided sufficient details regarding any corrective actions, documents, or a timeline for completion, to ensure these design control violations will be corrected at your facility.
3. Failure to establish and maintain procedures to ensure that all received product conforms to specified requirements, as required by 21 CFR 820.50. For example, your firm did not have a completed supplier evaluation form for your key supplier of nGenuity SpO2, CO2, analog, and main printed circuit boards (PCBA’s), as required by your own Purchasing Process, CTI 209, Rev E. This supplier has been providing these components to your firm since 2016 yet was listed on your approved supplier list as a probationary supplier.
We reviewed your firm’s response and concluded that it is not adequate. You have not provided sufficient details regarding any corrective actions, documents, or a timeline for completion, to ensure these purchasing control violations will be corrected at your facility.
4. Failure to establish and maintain procedures to control product that does not conform to specified requirements, including procedures to address the identification, documentation, evaluation, segregation, and disposition of nonconforming (NC) product, as required by 21 CFR 820.90(a). For example, six out of six nonconformance reports reviewed during the inspection did not include documented investigations or dispositions, as required by your procedure. These include:
NC 1797 dated August 4, 2022, for
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non-conforming SpO2 PCBs, p/n
(b)(4)
, lots
(b)(4)
and
(b)(4)
.
NC 1804 dated December 28, 2022, for
(b)(4)
non-conforming displays, p/n
(b)(4)
, lots
(b)(4)
, and
(b)(4)
.
NC 1786 dated November 8, 2023, for
(b)(4)
non-conforming
(b)(4)
, p/n
(b)(4)
, lot
(b)(4)
.
NC 1787 dated December 3, 2023, for
(b)(4)
non-conforming displays, p/n
(b)(4)
, lots
(b)(4)
and
(b)(4)
.
NC 1790, undated, for one damaged SpO2 analog ribbon cable, p/n
(b)(4)
NC 1796, undated, for
(b)(4)
non-conforming
(b)(4)
main PCBs covering the period 2/7/2022 - 7/21/2022.
We reviewed your firm’s response and concluded that it is not adequate. You have not provided sufficient details regarding any corrective actions, documents, or a timeline for completion, to ensure these NC violations will be corrected at your facility.
Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this 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 FD&C 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.
We are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirements of the device QS regulation (21 CFR, Part 820). You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:
Initial certifications by consultant and establishment – July 31, 2025
Subsequent certifications – July 31, 2026, and July 31, 2027
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 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 any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent to: Emma Schaefer, Acting Director of Compliance Branch, at oradevices1firmresponse@fda.hhs.gov. Refer to CMS # 686915 when replying. If you have any questions about the contents of this letter, please contact Compliance Officer, Karen Archdeacon at 781-587-7491 or at karen.archdeacon@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. 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/
Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
Division 1
Cc: Mr. Vinod Ramani, Chairman
Opto Circuits (India) Ltd.
#83 Electronics City, Bengaluru – 560 100, Karnataka, India
Email:
(b)(6)
Content current as of:
07/23/2024
Regulated Product(s)
Medical Devices