WARNING LETTER

Noah Medical Corporation MARCS-CMS 702414 — April 09, 2025

Delivery Method:: VIA Electronic Mail
Product:: Medical Devices

Recipient:: Recipient Name

Jian Zhang; Recipient Title

Chief Executive Officer; Noah Medical Corporation; 2075 Zanker Road
San Jose, CA 95131
United States; jianzhang@noahmed.com

Issuing Office:: Center for Devices and Radiological Health; United States

WARNING LETTER
CMS #702414

April 09, 2025

Dear Ms. Zhang:

During an inspection of your firm located at 2075 Zanker Road, San Jose, CA 95131 on October 28, 2024, through November 26, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures bronchoscopes and accessories (branded as the Galaxy System). 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 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 Richard W. Reeves, Vice President Quality Assurance and Regulatory Affairs, dated December 18, 2024, and January 21, 2025, concerning our investigators’ observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm¹. 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 establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a).

Specifically, your firm failed to adequately establish your “Corrective and Preventive Action (CAPA)” procedure (SOP-019 Rev. B, Effective Date: 10/30/2024), as your firm did not adequately conduct and document CAPA investigations. For example, according to your procedure, a Corrective Action/Preventive Action (CAPA) process shall be established to ensure “investigations are conducted to a degree sufficient to determine the root cause.” However, 2 out of 17 CAPA records selected for review by our investigators did not identify the root causes and necessary corrective and preventive actions as required by your CAPA procedure. The following describes the two CAPA records:

a. CAPA 24-007 dated 9/11/2024: Your firm failed to conduct adequate investigations as required by your CAPA procedure. For example, your firm failed to explore sufficiently to determine the root cause for “biopsy tools couldn’t pass through bronchoscope’s working channels.” You did not investigate, sufficiently to determine the root cause, the lot-to-lot variation of the distal end measurements of the working channels and how it may impact your root cause analysis.

b. CAPA 23-005 dated 4/14/2023: This CAPA record reported two scope pouches leaking due to the (b)(4) poking holes in the pouches during shelf-life/packaging transportation study Protocol “Design Verification Protocol for Bronchoscope Packaging,” (DOC: TP-099 Rev. B), and test report #WP-12154A. During execution of the (b)(4) aging testing of the sterile bronchoscope, a test failure was noted during a gross leak testing of the scope pouches. Your firm did not evaluate how many scope pouches were leaking to identify other potential causes of the failed leak test, such as quality issues with your suppliers. Subsequently, your scope pouches failed leak test during a (b)(4) aging study (test report number #WP-16128A), but your firm did not document the cause of the leak nor reference this failed leak test in CAPA 23-005.

We reviewed your responses, and their adequacy cannot be determined at this time. Your responses indicate that your firm initiated CAPA 24-028. You indicate that your firm made immediate corrections to CAPA 24-007; plans to contract with a third-party to retrospectively review all open and closed CAPAs, including the CAPAs cited during the last inspection; revised the CAPA process; and completed relevant training on the revised CAPA procedure including revised work instructions. However, the CAPA activities are still ongoing, and your responses do not clearly specify the target completion date for the overall CAPA 24-028 record.

2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

Specifically, your complaint procedure, “Complaint Management,” (SOP-025, Rev. G, Effective Date: 10/28/2024) has not been adequately established as your firm did not adequately conduct and/or document complaint investigations. For example,

a. Your procedure indicates complaint investigations are conducted to “determine the cause of any product defects and/or malfunctions, whether product met specifications, or whether product specifications were met, but were inadequate.” Your firm did not follow your procedure as exemplified below:

i. Complaint #00003531 described a failure to acquire live video feed upon attaching the scope to the instrument driving mechanism (IDM). Your firm did not adequately investigate the cause(s) of camera image loss.

ii. Complaint #00002229 involved a user experiencing scope buckling errors due to severe kink in the distal area and the user had to replace with another scope. However, your firm did not investigate cause(s) for the kinks.

iii. Complaint #00003614 described a patient experiencing excessive bleeding during Galaxy-assisted procedure. Complaint record states “scope buckling malfunction was observed.” However, your firm did not identify cause(s) for scope buckling.

b. Your procedure states complaint “investigation examples may include, but is not limited to … batch record review to determine if there were nonconformances, material used, or process steps that could have contributed to the complaint.” For complaint #00003610 involving a patient who had pneumothorax while undergoing a Galaxy-assisted biopsy procedure for a 14mm lesion in the left upper lobe, the patient got a chest tube insert and was admitted to the hospital for 3 days. Your firm did not review batch records and other quality data sources for the bronchoscope used in this procedure to investigate and determine whether your device could have contributed to the patient’s injury.

c. Your procedure states that “additional information from the complainant may be required to process a complaint” and that “various methods of communication … should be attempted in order to make a good faith effort to contact the complainant.” However, your firm failed to conduct and/or document a good faith effort to obtain additional information to support the complaint investigations. For example:

i. Complaint #00003544 has a death reported due to excess bleeding when a patient was undergoing a Galaxy-assisted bronchoscopy procedure. According to your firm’s representative and associated complaint record, the physician stated that “the patient had possibly forgotten to stop taking blood thinners” and patient possibly was “puncture[d] by biopsy forceps.” Your firm’s Clinical Engineer reviewed the video of the procedure and said she could not see the forceps puncturing the blood vessel because there was too much blood blocking the camera view. Your firm did not make any attempt(s) to verify the causes further.

ii. Complaint #00003337 involves a procedure that was aborted due to broken joysticks on two different controllers resulting in the scope drifting significantly into the patient’s right upper lobe of the lung. There was no documented information on when the patient was rescheduled for another procedure nor if the patient experienced any adverse event(s) after aborted procedures.

We reviewed your responses, and their adequacy cannot be determined at this time. Your responses indicate that your firm initiated CAPA 24-025, CAPA 24-026, and CAPA 24-015. Your responses indicate that your firm has made some progress including completion of the root cause investigation for CAPA 24-015. However, the CAPA activities are still ongoing for all three CAPA records, and your responses do not clearly specify the target completion dates for each overall CAPA record.

3. Failure to establish and maintain procedures for design control, as required by 21 CFR 820.30.

Specifically, your design control procedure, “Design Controls” (SOP-002, Rev. G, Effective Date: 10/21/2024), has not been adequately established.² For example, your design control procedure states that “Design verification and validation shall be conducted in accordance with SOP-033…to ensure design outputs meet the design input requirements and the product meets its intended use.” However, your firm failed to establish the procedure as follows:

a. Your firm failed to adequately conduct design validation for the (b)(4) biopsy tools, such as (b)(4), listed on page 23 of IFU Rev J, Effective Date: 09/25/2024. During design validation, your firm only performed design validation for the (b)(4) and used the (b)(4) as the worst-case tool for biopsy tool passage. Furthermore, your firm only tested biopsy tool passage in a (b)(4) configuration of the bronchoscope instead of (b)(4) configuration to account for bending of the bronchoscope. Your firm initiated CAPA 24-007 after the complaint trend associated with biopsy tools not passing through working channel “exceeded the required action threshold.”

b. Your procedure failed to define the requirements to test sterility as part of the shelf-life validations. Your bronchoscopes are sold as sterile with an expiration date of two years, but your firm did not test product sterility as part of the shelf-life validations in the following protocols:

i. Protocol #TP-008, Revision E, describing the (b)(4) aging study, titled: “Galaxy Bronchoscope Verification Test Plan” and Summary Report #TR-087, Revision C.

ii. Protocol #TP-008, Revision E, describing the (b)(4) aging study, titled: “Galaxy Bronchoscope Verification Test Plan,” and Summary Report WP-16128A, Date Reviewed 05/08/2024.

iii. Protocol #TP-099, Revision B, relating to the (b)(4) aging study, titled: “Design Verification Protocol for Bronchoscope Packaging (includes (b)(4) and (b)(4) configurations)” and Summary Report #TR-378, Revision A.

We reviewed your responses, and their adequacy cannot be determined at this time. Your responses indicate that your firm initiated CAPA 24-016 and CAPA 24-018. You indicate “as part of the Corrective Action, all instances of Design Verification and Validation of Requirements are being reviewed and where assumptions were made, these are being tested against documented evidence” (your firm’s response dated January 21, 2025). The CAPA activities are still ongoing for all three CAPA records, and your responses do not clearly specify the target completion dates for each overall CAPA record.

4. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).

Specifically, your procedure, “Nonconforming Material,” (SOP-018 Rev. G, Effective Date: 09/24/2024,), has not been adequately implemented. Your firm failed to conduct investigations to identify the root cause(s) as required by your nonconforming material procedure. For example:

a. NCR 0367 (Dated 04/11/2024) involves (b)(4) bronchoscopes failing leak test due to (b)(4) in the working channels (part (b)(4)). However, your firm did not conduct investigation to identify the root cause(s) of the (b)(4) nor implement a SCAR with your supplier.

b. NCR 0605 (Dated 09/20/2024) involves (b)(4) bronchoscopes failing leak tests. One failure was due to the working channel not adequately bonded to the (b)(4), and the other (b)(4) failures were due to (b)(4). However, your firm did not conduct investigation to identify the root cause(s) for the inadequate bonding nor the exposed (b)(4).

c. NCR 0071 (Dated 07/27/2023) involves (b)(4) working channels found to have kinks. However, your firm failed to investigate to identify the root cause(s) for the kinks nor implement a SCAR with your supplier.

We reviewed your responses, and their adequacy cannot be determined at this time. Your responses indicate that your firm initiated CAPA 24-021. Your responses indicate that your firm plans to update your procedures, conduct training once the revised procedures are complete, and address immediate issues including review of all NCRs to date (starting from May 2023, approximately (b)(4) NCRs) and identify those which require investigation or revisions. Also, you indicate that there was immediate containment for the NCRs cited during the recent inspection and your firm issued SCAR number 24-010 to your supplier to determine the root cause of working channel defects. However, the CAPA activities are still ongoing, and your responses do not clearly specify the target completion date for the overall CAPA record.

5. Failure to establish and maintain 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). Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the device history record (DHR), as required by 21 CFR 820.90(b)(2).

Specifically, your procedure, “Rework and Deviation,” (SOP-020 Rev. B, Effective Date: 11/28/2022), has not been adequately established. For example, your Rework and Deviation procedure failed to include the requirement for determining whether there has been any adverse effect from rework upon the product when documenting rework and reevaluation activities. For example, the DHR for “Galaxy, Cart, (b)(4)” CRB-1516 (part number (b)(4)), relates to nonconformance #108, which described a nonconformance with an instrument driving mechanism ((b)(4)) on the Galaxy System robot. This nonconformance resulted in frozen bronchoscope camera images. The (b)(4) were replaced. However, your firm did not document a determination of whether there has been any adverse effect from reworking the (b)(4) upon the “Galaxy, Cart, (b)(4)” CRB-1516.

We reviewed your responses, and their adequacy cannot be determined at this time. Your responses indicate that your firm initiated CAPA 24-022. Your responses indicate that you have revised your Rework and Deviation procedure and plan to conduct “a retrospective review of NCRs, rework, complaints and field repairs for all shipped systems to date as well as those in inventory to determine if any adverse effects are evident, and plan to implement corrections” (your response dated January 21, 2025). However, the CAPA activities are still ongoing, and your responses do not clearly specify the target completion date for the overall CAPA record.

Our inspection also revealed that your firm’s Galaxy Systems 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 devices that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

Failure to submit a report to FDA 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 #00003935 and #00003614 reasonably suggests that during a procedure where your firm’s Galaxy System was used, the patients sustained injuries resulting in bleeding that were treated with irrigation and suction (Complaint #00003935) and Levophed administration (Complaint #00003614). We determined that these interventions were necessitated to prevent permanent impairment of a body function or permanent damage to a body structure (21 CFR 803.3(w)(3)). Your firm became aware of Complaint #00003935 on August 21, 2024, and FDA has not yet received an MDR for the corresponding MDR reportable event.

Your firm became aware of Complaint #00003614 on July 24, 2024. Although the corresponding MDR #3021325287-2024-00024 was received by FDA on January 13, 2025, it was received beyond the 30-calendar-day timeframe.

The adequacy of your firm’s responses cannot be determined at this time. The responses indicate that your firm initiated a root cause investigation, plans to streamline its MDR reporting process, and is conducting a retrospective review of complaints for reportability. However, in the responses, your firm did not include documentation or evidence to demonstrate that the systemic corrective actions have been fully implemented, as these efforts are still ongoing.

Our inspection also revealed that your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, the document titled “Medical Device Reporting,” Doc# SOP-026, Rev. C, dated 10/28/2024, was presented as your firm’s written MDR procedure. After reviewing the MDR procedure, the following deficiencies were noted:

The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, the procedure omits the definitions of the terms “caused or contributed” from 21 CFR 803.3 and “reasonably suggests” found in 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).

Your firm’s responses did not address the noted procedural deficiencies, as these were not included in the FDA Form 483.

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 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 Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: cdrhenforcement@fda.hhs.gov. Please include in the subject line, CMS case #702414 when replying. If you have any questions about the contents of this letter, please contact: Linda Linh Adams, Compliance Officer, at lindalinh.adams@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 yours,
/S/

Matthew G. Hillebrenner
Deputy Director
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Cc: Sam Mostafavi, Regulatory Advisor/ Management Representative, at sammostafavi@noahmed.com

_______________________

1 FDA also received a response dated February 18, 2025. This letter does not address that response given timing considerations. That response will be considered along with any response to this letter.

2 Under 21 CFR 820.3(k), “establish” means define, document (in writing or electronically), and implement.