Tianjin Bolang Science-Technology Development Co., Ltd.

During an inspection of your firm located in Tianjin, China on March 22, 2021, through March 30, 2021, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Otoscopes, Rigid Laryngoscopes, and Rigid Nasopharyngoscopes. 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.

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 a response from Mr. Zhang Li, Management Representative, dated April 19, 2021, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address your response 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 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). For example, your firm has not established Design Control procedures for your firm’s private label manufactured endoscopic medical devices for the U.S. market, including the Class II Rigid Nasopharyngoscope. In addition, your firm did not conduct Design and Development activities for the Rigid Nasopharyngoscope. The activities not conducted include: Design Input, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, Design Changes, and Design History File.

The adequacy of your firm’s response cannot be determined at this time. Your firm identified its plan to establish a Design Control procedure according to 21 CFR 820.30, as well as establish a Design History File for products intended for distribution in the U.S. However, until your firm establishes Design Control procedures and a Design History File and provides a copy to the Agency for review, the adequacy of the response cannot be determined.

2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm has not established procedures for corrective and preventive action (CAPAs) and did not conduct any CAPAs. Your firm has also not established a system for the identification and input of quality data which may require corrective and/or preventive action.

We reviewed your firm’s response and conclude that it is not adequate. Your firm described its plan to revise the Improved Control procedures to meet requirements of 21 CFR 820.100. Also, your firm identified a planned retrospective review of quality data for the previous two years, performing corrective and preventive measures as needed. The response is not adequate because your firm did not provide details such as processes, work operations, quality records and other quality data to be analyzed. Since the investigator was not able to review and inspect production and process controls, procedures and records, FDA has no assurance quality data exists in order to perform a retrospective review. Additionally, the response does not describe how the CAPA procedure will be maintained and implemented.

3. Failure to maintain complaint files and to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm has not established customer complaint handling procedures to ensure it is receiving complaints from its sole U.S. distributor, Ecleris. This U.S. distributor is marketing your firm’s manufactured, private label, Rigid Nasopharyngoscope. Also, your firm does not have a written agreement with its U.S. distributor requiring all complaints be provided for review and evaluation.

We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated plans to update Measurement and Analysis of Customer Information Feedback Control procedures as required by 21 CFR 820.198 and to evaluate MDR reportable events as required by 21 CFR 803. However, during the inspection, complaint procedure and complaint records were not available for review. Therefore, a review of the procedures needs to be conducted in order to ensure it meets the requirements of 21 CFR 820.198 and details on how complaints will be retrospectively collected from customers, needs to be provided.

4. Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution, as required by 21 CFR 820.160. For example, your firm has not established procedures for the control and distribution of its private label manufactured endoscopic medical devices for the U.S. market including the Rigid Nasopharyngoscope to ensure only those devices approved for release are distributed.

We reviewed your firm’s response and conclude that it is not adequate. Your firm states that its customer related Process Control procedures will be revised to meet the requirements of 21 CFR 820.160. According to your firm, these revised procedures will include distribution requirements for product intended for the U.S. The response is not adequate because your firm has not identified a plan to establish and maintain procedures for the control and distribution of finished devices intended for the U.S.

5. Failure to maintain device master records (DMR's) and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. For example, your firm has not maintained Device Master Records (DMR’s) for its private label manufactured endoscopic medical devices intended for the U.S. market, including the Rigid Nasopharyngoscope.

The adequacy of your firm’s response cannot be determined at this time. Your firm stated that DMR Control procedures will be established in accordance with 21 CFR 820.181. The adequacy of the response cannot be determined until your firm establishes and maintains DMR Control procedures as required by 21 CFR 820.181, and provides a copy of the procedure to the Agency for review.

6. Failure to establish and maintain procedures to ensure that device history records (DHR’s) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of this part, as required by 21 CFR 820.184. For example, your firm has not established DHR procedures to ensure DHRs are maintained for each device batch, lot, or unit. Your firm also has not demonstrated DHRs are maintained for manufactured devices in accordance with specifications, including its private label Rigid Nasopharyngoscope.

The adequacy of your firm’s response cannot be determined at this time. Your firm states that DHR control procedures will be established to meet the requirements of 21 CFR 820.184. Until your firm establishes and maintains a DHR to demonstrate its device is manufactured in accordance with the device DMR as required by 21 CFR 820.184, and provides a copy of the procedures to the Agency for review, the adequacy of the response cannot be determined.

7. Failure to maintain a quality system record (QSR) which includes, or refers to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s), including, but not limited to, the records required by 21 CFR 820.20, as required by 21 CFR 820.186. For example, your firm ’s Quality System does not include, or refer to the location of procedures and the documentation of activities required by the Quality System regulation. During the inspection, certain procedures and documentation of the organizational structure were not available for review.

The adequacy of your firm’s response cannot be determined at this time. Your firm indicated its Quality System will be revised to include: 21 CFR 820; 21 CFR 803; 21 CFR 806; and 21 CFR 807. Revision of the Quality Manual and related procedures will also occur according to your firm. Until your firm establishes and maintains a Quality System and Quality Manual procedures as required by 21 CFR 820.186, and provides a copy of the procedures to the Agency for review, the adequacy of the response cannot be determined.

8. Failure to have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed, as required by 21 CFR 820.25(a). For example, your firm has not demonstrated it had any prior knowledge of U.S. FDA regulations and requirements including 21 CFR Part 820 - Quality System regulation.

The adequacy of your firm’s response cannot be determined at this time. Your firm described the completion of employee training for 21 CFR 820; 21 CFR 803, 21 CFR 807, 21 CFR 806 and 21 CFR 830. Until your firm can demonstrate adequate employee training for all personnel, related to its Quality System as required by 21 CFR 820.25, and provides a copy of the training for Agency review, the adequacy of the response cannot be determined.

Our inspection also revealed that your firm’s Class II Rigid Nasopharyngoscope 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, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.

We reviewed your firm’s response and conclude that it is not adequate. Your firm states MDR Control procedures will be established, and a complaint retrospective review will be conducted for MDR reportable events. However, the response does not include how the electronic submission of MDR reportable events to the Agency will occur. Until your firm develops, maintains, and implements written MDR procedures as required by 21 CFR 803.17, and provides a copy of the procedures for Agency review, the response is not adequate.

Given the serious nature of the violations of the Act, Otoscopes, Rigid Laryngoscopes, and Rigid Nasopharyngoscopes manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are addressed. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and address the violations described in this letter. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.

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.

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, including 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. Please provide a translation of documentation not in English to facilitate our review.

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 by email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #614851 when replying. If you have any questions about the contents of this letter, please contact Shu-Chen Peng, Ph.D. at (301) 796-6481.

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.