Global Medical Production Co Ltd MARCS-CMS 620544 — November 16, 2021

WARNING LETTER

• Product: Medical Devices

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• Recipient: Jeff Dai General; Manager & Co-Owner; Global Medical Production Co Ltd; No. 4 Building, No.3288; West Zhongshan Road; Xiuzhou Qu; Jiaxing Shi; Zhejiang Sheng, 314031; China

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

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WARNING LETTER

November 16, 2021

Dear Mr. Dai:

During an inspection of your firm located in Jiaxing, China on July 15, 2021 through July 30, 2021, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Sterile and Non-Sterile Electrosurgical Scissors, Sterile Electrosurgical Graspers, and Sterile Veress Pneumoperitoneum Needles. 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 two responses from you, dated August 19, 2021 and September 20, 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 this 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 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).

For example, your firm has not established Design Control procedures related to its private label manufactured medical devices intended for the US market to include Class II Sterile and Non-Sterile Electrosurgical Scissors, Class II Sterile Electrosurgical Graspers, and Class II Sterile Veress Pneumoperitoneum Needles. Additionally, your firm was unable to provide documentation and/or evidence of conducting Design and Development activities for these medical devices. This is a repeat violation from the previous inspection in April 2015.

We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that it would conduct training on 21 CFR 820.30 Design Control and Design Control Procedure, and retrospectively establish Design History Files for all products. The response also stated that your firm would provide training records, design history files for all of its products, effectiveness check reports, recommendations for additional actions or closure if applicable, and training records related to these corrective actions. However, the response did not indicate that there would be any assessment to determine the impact of the lack of design control activities for devices that were already distributed. Additionally, your firm has not provided documentation or evidence of implementation of a corrective action plan. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.

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

For example, your firm’s Nonconforming Product Control Procedure, Doc No. 28301, Ver. 2 and dated February 01, 2018; has no requirement for: the evaluation and disposition of nonconforming products, which should include procedures for determination of the need for an investigation and notification of the person or organizations responsible for the nonconformance. Additionally, during the inspection of your firm’s list of 2019-2021 nonconforming products, there was no documentation or evidence that your firm had conducted a determination of the need for an investigation or notification of the persons and organizations responsible for the nonconformance.

We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that it would revise the Nonconforming Product Procedure Document Number 28301 to add missing information for the evaluation and disposition of nonconforming products, which should include a determination of the need for an investigation and notification of the person or organization responsible for the nonconformance. Your firm also stated that it would retrospectively review the history of Nonconforming product and determine the need for an investigation as well as notification of the persons and organizations responsible for the nonconformance and disposition of the nonconforming product. Additionally, effectiveness checks would be initiated after all corrective and preventive actions were taken.  However, the response did not indicate that there would be an assessment to determine if the lack of disposition requirements led to a release of nonconforming product and how that risk will be addressed. Additionally, your firm has not provided documentation or evidence of implementation of the corrective actions as they are still ongoing. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.

3. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).

For example, your firm was not able to provide Performance Qualification (PQ) objective data and evidence or results of the PQ activities. Your firm stated that it does not have the results of the PQ conducted for its heat-sealing process validation activities, which is used in manufacturing processes of medical devices exported and intended for the US market. This is a repeat violation from the previous inspection in April 2015.

We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that it would execute a new Performance Qualification and would also assess all other processes and Performance Qualifications for objective data and results. A new Performance Qualification would be executed where data or results were not found. Your firm stated it would provide the agency with PQ data, its PQ summary Report, effectiveness check reports, recommendations for additional actions or closure if applicable, and training records. However, the response did not indicate that there would be any corrective actions to ensure that the firm maintains such records in the future. Additionally, your firm has not provided documentation or evidence of implementation of the corrective actions as they are still ongoing. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. We request this information to assess whether these correction actions were completed.

4. Failure to conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules, as required by 21 CFR 820.70(g)(1).

For example, your firm has not established a maintenance schedule for your Production Controlled Room Air Handling HEPA Filters and Water Purifier, Equipment No. 08, used in the ultrasonic cleaning of components of your firm’s private label manufactured medical devices intended for the US market, to include Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Scissors, Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Graspers, and Class II Sterile Veress Pneumoperitoneum Needles.

We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that it would establish a maintenance schedule for the Production Controlled Room Air Handling HEPA Filters and Water Purifier Equipment No. 08. Your firm stated that it would provide training for new procedure and provide the agency with records of the retrospective schedule, maintenance schedules, effectiveness check reports and a recommendation for additional actions or closure. However, the response did not indicate that there would be an assessment to determine the impact from the lack of maintenance schedule on previously released product. Additionally, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. We request this information to assess whether these correction actions were completed.

5. Failure to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria, as required by 21 CFR 820.86.

For example, your firm had product in the warehouse that was labeled as “sterile” and was intended for the U.S. market. However, the product should have been identified as "Non-Sterile” to indicate its non-processed and non-sterile status to ensure only medical devices that have undergone the sterilization process are accepted and distributed to the US market. Your firm stated that it has no process or requirement to ensure “Non-Sterile” product is conspicuously labeled to indicate its non-processed, non-sterile status from sterile product. Your firm does not follow its Nonconforming Product Control Procedure, Doc No. 28301, Ver. 2 and dated February 01, 2018. Medical device components and finished medical devices were not properly identified to ensure that only product which has passed the required acceptance activities are distributed or used.

We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that your firm would revise Document 27502, Product Identification and Traceability to add method for identifying the status of product. Your firm also plans to establish a new procedure to address placing the sterile indicator label on the product package to identify product before and after the process of sterilization by December 15, 2021. Your firm will establish a new procedure for physically separating product and identifying each location with product status. Document 28301, section 6.3.2.1 and 6.3.2.2, will be revised to remove sections for green and red labels and replace with a label that has a section to indicate accept or reject status. The Identification Procedure will be revised to include physical storage area status.

A new procedure will be established to identify scrap product with "not for human use label." Your firm will identify storage areas in the facility with proper identification and segregate manufacturing and storage areas to prevent possible mix-ups. Products will be quarantined in the unmarked storage room and assign a Non-Conformance Number to the product, disposition of the product, and identity of the product. Additionally, upon completion of all corrective and preventive actions, your firm will conduct an effectiveness check. Based on results of the effectiveness check, GMP may recommend additional actions or closure of this observation. However, the response did not indicate that there would be an assessment to determine if the lack of adequate identification led to the release of unsterilized product. Additionally, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.

6. 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).

For example, your firm’s Customer Complaint Control Procedure, Doc No. 28502, Ver. 3, and dated February 01, 2018, has no requirement to ensure your firm is receiving complaints from its sole distributor that is marketing and selling its private label manufactured medical devices in the US market. Additionally, your firm has no documented agreement with its sole US private label distributor requiring them provide your firm with complaints to ensure that it reviews and evaluates all complaints in a uniform and timely manner to determine whether an investigation is necessary and are evaluated to determine whether the complaint represents an event, which is required to be reported to the USFDA under 21 CFR Part 803 - Medical Device Reporting (MDR).

We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that it executed a Quality Agreement with its US Distributor that requires the distributor to provide your firm with complaints and provided the agency with a copy of this agreement. Your firm’s response stated that it would revise its Customer Complaint Procedure and retrospectively establish a Customer Complaint Log to record complaint activities. Additionally, the response stated that it would review and evaluate all complaints in a uniform and timely manner to determine whether an investigation is necessary. The response also stated that it would provide the agency with its revised procedure, customer complaint logs, effectiveness check reports, recommendations for additional actions or closure if applicable, and training records related to these corrective actions. However, the response did not indicate that there would be a retrospective assessment to determine if the complaints previously received by the initial importer present quality problems that were previously unknown. Additionally, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.

7. Failure to maintain device master records as required by 820.181.

For example, your firm has not maintained Device Master Records related to your firm's private label manufactured medical devices for the US market to include, Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Scissors, Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Graspers and Class II Sterile Veress Pneumoperitoneum Needles.

The adequacy of your firm’s response cannot be determined at this time. Your firm stated it would conduct training to 21 CFR 820.181 its Quality Manual Procedure Document Number 24101, and retrospectively establish a Device Master Records for all products. The response also stated that it would provide Device Master Records for all products, effectiveness check reports, recommendations for additional actions or closure if applicable, and training records related to these corrective actions. However, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.

8. Failure to maintain device history records as required by 820.184.

For example, your firm was not able to provide device history records for private label manufactured medical devices intended and exported to the US market, to include Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Scissors, Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Graspers and Class II Sterile Veress Pneumoperitoneum Needles.

The adequacy of your firm’s response cannot be determined at this time. Your firm’s response stated that it had a device history record for all of its products but that it had not been translated during the inspection. Your firm stated that it would provide a device history records for each product that it would provide recommendations for additional actions. However, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.

Our inspection also revealed that your firm’s 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 a Medical Device Reporting (MDR) procedure, as required by 21 CFR 803.17. For example, during the inspection, your firm acknowledged that it does not have an MDR procedure. This is a repeat violation from the previous inspection in April 2015.

The adequacy of your firm’s response cannot be determined at this time. The response noted the following corrective actions: Implement a Medical Device Procedure compliant with 21 CFR 803.17 by September 30, 2021, perform a retrospectively review of all complaints from 2018 to present to evaluate for MDR reportability and submit all the identified MDRs by December 1, 2021 and Perform effectiveness check and report to the FDA within 90 days of completing all corrective and preventative actions. However, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. We request this information to assess whether these correction actions were completed.

Given the serious nature of the violations of the Act, Sterile and Non-Sterile Electrosurgical Scissors, Sterile Electrosurgical Graspers, and Sterile Veress Pneumoperitoneum Needles 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 violation(s) described in this letter. We will notify you regarding the adequacy of your firm’s response(s) 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 # 620544 when replying. If you have any questions about the contents of this letter, please contact: Long Chen at (301) 796-6389.

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/

Binita S. Ashar, MD, MBA, FACS
Director
OHT 4: Office of Office of Surgery and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological
Health

CC:
Mike Athey
2526 Old Lake Mary Road
Sanford, FL 32773