问：FDA Warning Letter有样办吗？
答：以下为FDA的审厂Warning Letter样办：
WARNING LETTER
Wickimed Medical Equipment Manufacturing Co., Ltd.MARCS-CMS 623042 — JANUARY 07, 2022
Product:
Medical Devices
Recipient:
Mac Lai
CEO
Wickimed Medical Equipment Manufacturing Co., Ltd.
XingWang Street, LiLin TownZhongKai Hi-Tech ZoneHuizhou Shi Guangdong Sheng, 516003China
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
January 7, 2022
Dear Mr. Lai:
During an inspection of your firm located in HuiZhou China, on September 6, 2021 through September 14, 2021, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Class II Sterile Single Use Disposable Electrodes. 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 response from you dated October 3, 2021 and October 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 these responses below, in relation to each of the noted violations.
Your firm’s responses dated November 24, 2021 and December 20, 2021 to the Form FDA 483 (FDA 483) was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. 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 Control Procedures for Customer Feedback, Complaints and Return, (b)(4) and dated (b)(4), has no requirement to ensure your firm is receiving complaints from its distributor that is marketing and selling the private label manufactured medical devices in the US market. Additionally, your firm has no documented agreement with its US private label distributor requiring them to provide your firm with complaints. It is important that your firm reviews and evaluates all complaints in a uniform and timely manner to determine whether an investigation is necessary and that they are evaluated to determine whether the complaint represents an event that is reportable under 21 CFR Part 806, Medical Device Reporting.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided their revised Customer Feedback, Complaints, and Returns procedure, which your firm indicates establishes responsibility for complaint handling activities. Your response stated that this included the firm’s need to evaluate complaints to determine if an investigation is necessary and should be reported to the US FDA, for all new and existing customers. Your firm’s response stated it conducted the following actions:
· Reviewed the FDA MAUDE database for the past 5 years and initiated customer complaints for the 3 MDRs found in order to perform complaint investigations.
· Revised its Contract Review Procedures.
· Provided training to the related personnel on both revised procedures. Retrospectively reviewed the EUDAMED and NMPA databases and found no complaints relating to your devices.
However, the documents your firm provided are written mostly in a foreign language with limited English translated sections. Therefore, it is not possible to conduct a full assessment of the response for adequacy. Your firm should provide a complete English translated version of its documents to the FDA. Additionally, your response does not reveal if the distributor has been contacted to determine if any complaints have been received.
2. Failure to adequately ensure that 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 began sterilization activities for their private label sterile medical devices and contract manufactured medical devices on December 23, 2019. During the inspection, your firm was not able to provide detailed information on the sterilization validation process, nor objective evidence and data.
We reviewed your firm’s response and conclude that it is not adequate. Your firm acknowledges that it did not retain the raw data to support the report as there was no requirement for handwriting the data in its procedures. Your firm’s response stated that it conducted the following actions:
· Reviewed its data for sterilization cycle records and were able to determine that there were no Biological Indicator failures for the past 3 years.
· Reviewed its customer complaints for the past three years to determine whether there were any complaints related to inadequate sterilization process or the sterility of their product.
· Conducted IQ/OQ revalidation for the sterilization chamber that did not have handwritten data.
· Provided its draft Product Registration and Marketing Authorization control procedure.
· Provided its Revised Sterilization Process Control procedures.
· Conducted training on its new procedures.
However, the documents your firm provided are written mostly in a foreign language with limited English translated sections. Therefore, it is not possible to conduct a full assessment of the responses for adequacy. Your firm should provide a complete English translated version of its documents to the FDA.
3. 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 adequately established Design Control procedures related to its line of private label manufactured Sterile Single Use Disposable Electrodes that are exported and intended for the US market. Your firm stated that it was not familiar with or could not provide the following:
· Its design and development procedures.
· Explain what design and developments activities were conducted and the results.
· Provide nor locate all the documentation related to the Class II Sterile Single Use Disposable Electrodes (GEI), DHF and 510(k).
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that your firm conducted the following actions:
· Provided its revised Design and Development Management Procedure and trained its related personnel on the revised procedures.
· Conducted reverification and revalidation on the microneedles.
· Conducted a retrospective review of its DHF and found some missing objective data and evidence for its Electrosurgical Pencil with Electrode WP 200 Series.
· Conducted reverification and revalidation on the Electrosurgical Pencil with Electrode WP 200 series.
· Reviewed your design verification and validation for your other products and determined that the design verification and design validation reports had included objective data and evidence.
4. 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 has not established procedures to properly identify medical devices labeled as "Sterile", which have not undergone the sterilization process are properly and conspicuously identified as "Non-Sterile” to indicate its non-processed, and non-sterile status to ensure only medical devices, which have undergone the sterilization process are accepted, and distributed to the US market. Additionally, during the inspection of the off-site EtO Sterilization Facility your firm had multiple pallets of various finished Class II medical devices intended for the US market labeled as "Sterile", which had not undergone the sterilization process.
· Provided its revised Product Identification and Traceability Procedure, which your firm states updates the requirements to add labeling to devices to denote sterilization status.
· Established a sample management procedure to define how to manage the sample used for registration test, design, and development.
· Trained personnel on these procedures and executed sample management control.
· Reviewed its other product lines within its facilities to determine if they lacked proper labelling of sterilization status.
· Checked raw materials, components, labelling, and finished medical devices throughout its facility to determine if there were other products that lacked sample labeling.
However, the documents the firm provided are written mostly in a foreign language with limited English translated sections. Therefore, it is not possible to conduct a full assessment of the response for adequacy. Your firm should provide a complete English translated version of its documents to the FDA. Additionally, your firm has not conducted a retrospective review to determine whether unsterilized product was released.
5. Failure to establish and maintain procedures to control all documents as required by 21 CFR 820.40.
For example: Your firm’s document control procedure, Company Operation Control Procedure, (b)(4) and dated (b)(4), has not been adequately established to ensure only approved documents are distributed throughout the facility. Several documents were found within the facility outside of their designated locations. These documents include but are not limited to Internal Quality Audits records, sterilization notice forms, sterilization validation records, sterility test records.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that it conducted the following actions:
· Provided its revised Quality Record Procedure, which it has implemented and has retrained its related personnel.
· Reviewed its entire facility to ensure that all controlled documents were properly stored in their new designated locations.
· Performed a retrospective review of all of its quality records to ensure that they were placed in the correct location.
However, the documents your firm provided are written mostly in a foreign language with limited English translated sections. Therefore, it is not possible to conduct a full assessment of the response for adequacy. Your firm should provide a complete English translated version of its documents to the FDA. Additionally, your firm did not assess whether the uncontrolled documents may have led to nonconformities.
6. Failure to maintain device history records as required by 820.184.
For example: The device history records (DHRs) did not contain the labeling required by the DHR procedure, Product Batch Record Control Procedure, (b)(4) and dated (b)(4).
· Retrained its related personnel in its Product Batch Record Control Procedure.
· Required that all the DHRs contain the labeling for photographed and printed product carton main mark and side mark.
· Retrospectively reviewed all of its DHR reports for all of the products destined for your firm’s U.S. customers.
However, the documents your firm provided are written mostly in a foreign language with limited English translated sections. Therefore, it is not possible to conduct a full assessment of the response for adequacy. Your firm should provide a complete English translated version of its documents to the FDA.
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 Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
For example: During the inspection, your firm acknowledged that its MDR procedure titled “Control Procedure for Issuance and Implementation of Adverse Event”, (b)(4), dated (b)(4), does not contain information indicating that it is an MDR procedure created in accordance with the requirements in 21 CFR 803.17.
We reviewed your firm’s response and conclude that it is not adequate. The response included a copy of your firm’s revised MDR procedure titled “Control Procedure for Issuance and Implementation of Adverse Event”, (b)(4), dated (b)(4). It also includes evidence that personnel were trained and a statement indicating that your firm plans to conduct a retrospective review of its complaints by November 20, 2021. However, the revised MDR procedure (b)(4), is written mostly in a foreign language with limited English translated sections. As such, FDA was unable to conduct a full assessment for adequacy of your firm’s MDR procedure. Your firm should provide a complete English translated version of its MDR procedure to the FDA. In addition, there is no evidence your firm’s retrospective review was completed as such actions were ongoing at the time the response was received.
Given the serious nature of the violations of the Act, the Class II Sterile Single Use Disposable Electrodes 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 implementation 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 action (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. 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. 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 # 623042 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
Office of Surgery and Infection Control Devices
Office of Product Quality and evaluation
Center for Devices and Radiological Health
CC:
Mr. David Lennarz
Registrar Corp
144 Research Drive
Hampton, VA 23666
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