P.T. Sankei Medical Industries

During an inspection of your firm located in Banten, Indonesia on May 8, 2023, through May 11, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Sphygmomanometer Unit (Adult and Large Adult), Single Use, Latex Free device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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.

We received a response from you dated May 24, 2023, concerning our investigator(s)’ observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address these responses below, in relation to each of the noted violations, and any additional responses will be reviewed as part of your warning letter response.

You currently have a clearance for the Aneroid Sphygmomanometers/Mercurial Sphygmomanometers under K942543. Our inspection revealed that your firm made changes to the materials of the cleared device without submission of a new 510(k). As explained in Section C.4.1 of the guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device1 (“510(k) Modifications Guidance”) in general, changing the material may affect the biocompatibility of the device. Thus, these changes could significantly affect the safety or effectiveness of the device and required the submission of a new 510(k). 21 CFR 807.81(a)(3)(i). Your response did not address this violation.

Accordingly, the Sphygmomanometer Unit (Adult and Large Adult), Single Use, Latex Free device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency.21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

This inspection also revealed that this device is 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 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 Design and Development Procedure (Document #PS-17, Revision 00) is a process for the development of new systems and products as well as existing ones in order to meet external and internal customer requirements. This procedure was not applied to the Sphygmomanometer Unit (Adult and Large Adult), Single Use, Latex Free device since design controls have not been conducted for the single use sphygmomanometer.

We reviewed your firm’s response and concluded that it is not adequate. The response included an updated version of the Design and Development Procedure; however, the supporting documents provided were not in English and could not be reviewed. In response to this Warning Letter, you should provide evidence of the corrective actions. For example, this should include documentation and confirmation the design controls were applied to the Sphygmomanometer Unit (Adult and Large Adult), Single Use, Latex Free device. Please provide all responses and documentation in English or with English translations.

2. Failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21CFR 820.50. For example:

Your Purchasing Procedure (Document #PS-04, Revision 03) requires samples made by potential suppliers to be checked by Quality Assurance (QA). However, this procedure does not detail the specified requirements, including quality requirements, that potential suppliers and contractors must meet. Further, you do not have an agreement with suppliers and/or contractors that requires notification of changes in the product to ensure changes do not affect quality of finished devices. We reviewed your firm’s response and concluded that it is not adequate. The response included an updated version of the Purchasing Procedure; however, the new version did not address the deficiencies noted above. Further, the supporting documents provided were not in English and could not be reviewed.

In response to this Warning Letter, you should provide updated documentation including, but not limited to, an updated Purchasing procedure and documentation of agreements with suppliers and/or contractors. You should also provide evidence of the corrective actions. Please provide all responses and documentation in English or with English translations.

3. Failure to adequately ensure Design History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184 For example:

Your Quality Plan for (b)(4) (Document #QP-DC-0001A, Revision 2) details the required manufacturing steps for the following procedures/work instructions including, but not limited to: (b)(4), and (b)(4). However, your firm’s DHRs did not include or refer to the location of the primary identification label and labeling used for each production case. Further, the procedure does not require manufacturing step documentation. Specifically, it does not require technician(s) to document manufacturing/operation steps in the production record nor utilize any forms to document the manufacturing/operation steps.

We reviewed your firm’s response and concluded that it is not adequate. The response included an updated version of the Quality Plan; however, the new version did not address the deficiencies noted above. Further, the supporting documents provided were not in English and could not be reviewed. In response to this Warning Letter, you should provide updated documentation including, but not limited to, updated DHRs for the Sphygmomanometer Unit (Adult and Large Adult), Single Use, Latex Free device, updates to the DHR procedures and forms. You should also provide evidence of your firm’s corrective actions. Please provide all responses and documentation in English or with English translations.

4. Failure to adequately maintain device master records (DMR's), as required by 21 CFR820.181 For example:

Your Device Master File Procedure (Document #PS-33, Revision 0) requires each DMR to include a Quality Assurance and Reference Documentation section. However, the DMR for the Sphygmomanometer is missing documentation of the Quality Assurance and Reference Document sections. Further, the DMR for the Sphygmomanometer Product has not been reviewed and approved through document controls.

We reviewed your firm’s response and concluded that it is not adequate. The documents were not provided in English and could not be reviewed. In response to this Warning Letter, you should provide evidence of the corrective actions. For example, this should include updated documentation including, but not limited to, updated DMRs for the Sphygmomanometer Unit (Adult and Large Adult), Single Use, Latex Free device. Please provide all responses and documentation in English or with English translations.

5. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198. For example:

Your Customer Claim Handling procedure (Document #PS-15, Revision 01) requires “preventive and corrective actions for the problem must be completed”. However, the procedure does not require review and evaluation of all complaints to determine whether an investigation is necessary, nor does it require the manufacturer to maintain a record that includes the reason no investigation was needed and the name of the individual responsible for the decision not to investigate. Further, it fails to require events meeting the definition of a complaint under 820.3(b) be evaluated to determine whether the complaint represents an event for which reporting is required under 21 CFR part 803, Medical Device Reporting. The procedure states that the Corrective and Preventive Action form is used to document customer claims. The form does not record manufacturer review and evaluation of complaint to determine whether an investigation is necessary.

We reviewed your firm’s response and concluded that it is not adequate. The response included an updated version of the Customer Claim Handling procedure; however, the new version does not address the deficiencies noted above. Further, the supporting documents provided were not in English and could not be reviewed. In response to this Warning Letter, you should provide evidence of updated documentation including, but not limited to, updates to the Customer Claim Handling procedures and forms as well as evidence of the corrective actions. Please provide all responses and documentation in English or with English translations.

6. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system complies with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example:

Your Audit Management System Procedure (Document #PS-02, Revision 03) requires audits to be conducted (b)(4); however, there is no documented evidence to show that the scheduled items/processes of the quality system were audited for 2022 or 2023.

We reviewed your firm’s response and concluded that it is not adequate. The response included a version of the Audit Management System Procedure; however, the supporting documents provided were not in English and could not be reviewed. In response to this Warning Letter, you should provide an updated documentation including, but not limited to, documentation confirming audit performance and updated Audit Process.

Please provide all responses and documentation in English or with English translations.

Our inspection also revealed that your firm’s Sphygmomanometer Unit (Adult and Large Adult), Single Use, Latex Free device is 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 adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “Medical Device Adverse Events and Advisory Notice Report”, Document #PS-25, Revision 00, dated 3/2/2023, the following deficiencies were noted:

1. 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, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) 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).

2. Your firm’s procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example: a. There are no instructions for investigating each MDR reportable event and evaluating the cause of the event. b. The procedure, as written, does not specify who makes the decision for reporting events to FDA. c. There are no instructions for how the firm will evaluate information about an event to make MDR reportability determinations in a timely manner.

3. Your firm’s procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3).Specifically, the following are not addressed: a. Instructions for how to obtain and complete the FDA 3500A form. b. The circumstances under which the firm must submit initial 30 days, supplemental or follow-up, 5-day report and the requirements for such reports. c. A process for submitting initial and supplement or follow-up reports to FDA in an electronic format that FDA can process, review and archive in accordance with 21CFR 803.12(a). d. How your firm will submit all information reasonably known to it for each event. Specifically, which sections of the 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow up within your firm.

4. Your firm’s procedure does not describe how your firm will address documentation and record-keeping requirements, as required by 21 CFR 803.17(b), including: a. Documentation of medical device reports submitted to FDA. b. Information that was evaluated to determine if an event related to death, serious injury, or malfunction was reportable. We reviewed your firm’s response and concluded that it is not adequate. Your response included a revised MDR procedure titled “Medical Device Adverse Events and Advisory Notice Report”, Document #PS-25, Revision 01, dated 5/15/2023. However, the revision did not address the deficiencies noted above.

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 product is 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 via 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, FDA Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 665754 when replying. If you have any questions about the contents of this letter, please contact: Stephen Browning at (240) 402-5241 or Stephen.browning@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 product into compliance.