- Medical Devices
Recipient NameMr. Ming Fai Sham
Recipient TitleChairman, Owner
- Dongguan Microview Medical Technology Co., LTD
Bihu Ave., Jinqi Rd., Bldg. # 3; 6-7 Floors
Feng Gang Town
Guangdong Sheng, 523695
- Issuing Office:
- Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993
September 20, 2019
Dear Mr. Sham:
During an inspection of your firm located in Guangdong, China on June 24, 2019 through June 27, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the MicroView Disposable Endoscopic Cannula. 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. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control product that does not conform to specified requirements. The procedure shall address the identification of nonconforming product as required by 21 CFR 820.90(a).
During a walk-through inspection of your facility, there were bins of finished devices and subassemblies the lacked the product identification and/or acceptance status labels. These products were identified by your employee as nonconforming products.
2. 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).
a. Your firm failed to adequately validate and document the related activities for ethylene oxide (EO) sterilization.
i) For the EO sterilization process validation (EO Sterilization Process Validation Protocol & Report, (b)(4)), you failed to document the rationale for the selected Process Challenge Device (PCD), Biological Indicator (BI) placement in the device, the location of the PCDs in the load, and product sample size of (b)(4) used in the acceptance activities.
ii) The disposable endoscopic cannulas are initially packaged into a sealed pouch then placed in a shelf carton. (b)(4). In addition, the sterilized product goes through a (b)(4) packaging process, (b)(4). Your firm did not validate the (b)(4) pouch packaging process.
iii) According to the Packaging Validation Plan dated April 11, 2018 for the sealing process, the validation was performed at a temperature of (b)(4). However, the Initial Packaging Instructions, (b)(4) which is the SOP that controls the packaging process, the parameters are (b)(4) at feeding depth (b)(4).
3. Failure to ensure that when changes or process deviation occur, the manufacturer shall perform revalidation where appropriate, as required by 21 CFR 820.75(c).
a. Your firm did not revalidate the primary sealing packaging process after the process was relocated on January 16, 2019. The last primary sealing packaging process validation you performed was in November 4, 2018 at the previous facility.
4. Failure to establish and maintain procedures to include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
a. Your firm initiated two corrective and preventative actions (CAPAs) (CAPA No. 20190122001 & 20190122002) where corrective actions were implemented and closed; however, the effectiveness verification of the corrective action was not verified, and there was no documented information for the decision.
i) CAPA No. 20190122001 was initiated on missing product acceptance labels for received disposable endoscopic cannula plastic handle housing stored in the accepted incoming material warehouse. Your firm found this to be due to the employees not following the procedure. The corrective action taken was to produce a new acceptance level for the implicated case product and perform inspection of the specific lot by visually examining to ensure the label was present on the rest of the cases from the product lot. The employees were also retrained and the CAPA was closed after implementation and same day training was conducted. No effectiveness verification was performed. In addition, a walk-through inspection of your facility revealed various cases of product in the various areas that lacked the required acceptance and identification labels.
ii) CAPA No. 20190122002 was initiated because the supplier names such as the supplier for the custom electrical cable for the disposable endoscopic cannula were not included on the Qualified Supplier List. This was also identified as employee error. The corrective action was to revise the qualified supplier list, retrain the employees and review the accuracy of the list. The CAPA was closed after implementation of the corrective actions. No effectiveness verifications were performed.
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.
a. During a walk-through of your facility, various products were observed that lacked the product identification and/ or acceptance status labels.
i) There were cases of various raw materials without acceptance status label in the raw material storage room
ii) There were unidentified bins of components stored on the floor in the ultrasonic cleaning room; also, the status of the components as to whether they were cleaned or awaiting cleaning was not identified
6. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).
a. During the inspection, your firm could not provide the internal auditors training record for the internal audit procedure and the job-related training records for two employees who were also internal auditors. You stated that these employees “only received external training.” Additionally, your firm did not have documented job-related training records for the two individuals.
7. Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j).
a. Your firm’s design history file for the Sterile Disposable Endoscopic Cannula is not adequately maintained. Your firm was unable to provide the documents related to the 2016 packaging process validation that was performed after a change in the device packaging material.
i) Your firm’s supplier made a design change in 2016 to the device sterile Tyvek packaging pouch material. You stated that a risk evaluation was conducted based on the information provided by the supplier of the Tyvek material. In addition, your firm provided documentation on the Disposable Cannula Package Validation Plan (b)(4), however, you were unable to provide the related documents. You stated that the validation report, supporting data and records were lost.
Given the serious nature of the violations of the Act, the MicroView Disposable Endoscopic Cannula 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 corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct 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.
Also, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected.
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 correct 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.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2, FDA Inspections and Regulatory Audits Team, White Oak Building 66, Rm 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 578924 when replying. If you have any questions about the contents of this letter, please contact: Sharon Andrews, Acting Director at (301) 796-6529.
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 the violations and take prompt actions to correct the violations and bring the products into compliance.
Benjamin R. Fisher, Ph.D.
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Hlongmed International Ltd.
4951 Netarts Hwy West
Tillamook, OR 97141