- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Medical Devices
Recipient NameIn Hwan Choi
- Philosys Co. Ltd
- Issuing Office:
- Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
January 14, 2020
Re: FDA Reference Number: CMS#582516
Dear Mr. In Hwan Choi:
During an inspection of your firm located in Gunsan-si, Korea on August 27-30, 2018, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Self-Monitoring Blood Glucose (SMBG) test systems. 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 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.
We received a response from Se Hun Kwon, Quality Management Representative dated September 17, 2018 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 submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
For example, the information included for the draft Medical Device Report (MDR) K113636-2015-00001 (corresponding to Complaint CS15-0420-01 and MedWatch Report MW5042272) reasonably suggests that a diabetic patient who takes prescription Lantus insulin experienced an injury (e.g. hypoglycemia due to excess insulin) as a result of a malfunction (i.e. false high glucose readings) of your firm’s Gmate VOICE blood glucose monitoring system. Medical intervention was necessitated to preclude permanent impairment of a body function or permanent damage to a body structure. Although you noted that you submitted on April 20, 2015, an MDR report for Complaint CS15-0420-01, FDA has not yet received an MDR corresponding to the referenced event. Please note that the corresponding complaint file was written in a foreign language. As such, your firm should also provide an English translation of the referenced complaint.
The adequacy of the response dated September 17, 2018 cannot be determined at this time. In the response, your firm noted that it planned to complete its investigation of the referenced complaint and revise its related procedural documents. However, your firm did not provide documentation or evidence of implementation of its systemic corrective actions, including a retrospective review of all adverse events to ensure that reportable events are timely submitted to FDA.
2. Failure to maintain information in your possession or references to information related to the adverse event, including all documentation of your deliberations and decision making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable under 21 CFR 803, as required by 21 CFR 803.18(b)(1)(i). For example, at the time of our inspection, FDA’s review of the information in Complaint File CSKR-1803-01 revealed a lack of documentation of your decision making process.
The adequacy of the response dated September 17, 2018 cannot be determined at this time. In the response, you noted that you planned to complete your investigation of the referenced complaints and update your related procedural documents. However, you did not provide documentation or evidence of implementation of your planned systemic corrective actions.
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.
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. 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.
In addition to the violations above, we have noted the following nonconformances. These nonconformances were documented on the FDA 483 issued at conclusion of the inspection and formally discussed with your firm’s management. We are not pursuing further regulatory action on these objectionable conditions at this time, however you should take prompt action to correct these nonconformances. The Center for Devices and Radiological Health, received and reviewed your response to the FDA 483, dated September 17, 2018. These nonconformances include, but are not limited to, the following:
1. Failure to adequately establish procedures for changes to a process, as required by 21 CFR 820.70(b). Specifically, your firm did not adequately verify or validate the following two changes made to the Gmate glucose test strip production process in 2016.
a. Your test strip sheet printing supplier was changed on January 2, 2016. Your firm’s Design and Development Control Procedure requires that your firm perform full performance and stability testing after each major change, such as a sheet printing supplier change. However, the only documented performance or stability testing your firm completed was a stability study performed at room temperature over (b)(4) days. The Gmate Design History Record (DHR) for test strip lot GM10RFSO specifies that the test strips have a shelf life of two years at storage temperatures of 2-32 °C and can be used for three months after the test strip vial is opened according to the device label. The stability testing performed by your firm does not demonstrate that the test strips will give accurate results across the full storage and use conditions the device is specified for. Your firm could not provide any other evidence that the Gmate test strips from the new test strip sheet printing supplier met the performance specifications on the device label or in the DHR.
b. Your quality control procedure including sampling plan and testing steps was changed on 09/01/2016. Your firm’s test strip sheet printing supplier changed the batch size from (b)(4) sheets per batch to (b)(4) sheets per batch. As a result of this supplier change, your firm amended your quality control sampling plan from testing one sheet of every (b)(4) sheets manufactured to testing one sheet of every (b)(4) sheets manufactured. Your firm’s Design and Development Control Procedure requires that your firm complete a change review for this modification to their quality control testing. Your firm could not produce any documentation of this change review so there is no evidence that your firm’s reduced frequency of quality control testing is adequate for the (b)(4) sheet batches of test strips.
These two changes were not adequately verified or validated to ensure the Gmate glucose test strips still meet your specification for performance, storage temperature and relative humidity, or stability. In addition, insufficient review of changes was executed for these two changes per your firm’s change control procedure ((b)(4)).
Your firm’s response dated 09/17/2018 is not adequate because the CAPA results were not provided for review. In addition, your proposed CAPA did not include a systemic review of other design changes or manufacturing processes. A systemic review is needed to determine whether adequate validation was previously completed for all change processes. Lastly, your firm did not discuss training of personnel on updated processes which is needed for the CAPA to be adequate.
2. Failure to submit initial and supplemental or follow up reports to FDA in an electronic format that FDA can process, review, and archive, as required by 21 CFR 803.12(a). For example, during the inspection, your firm stated that a draft MDR K113636-2015-00001 (corresponding to MedWatch Report MW5042272, Exhibit 43) was submitted to FDA in 2015. However, FDA has not yet received the referenced MDR. In addition, based on FDA’s records your firm had a certificate with Electronic Submissions Gateway (ESG) on 10/16/2018. However, it does not complete its load test and guidance compliance submission for electronic Medical Device Reporting (eMDR). Your firm needs to follow the instructions located at: https://www.fda.gov/medical-devices/emdr-electronic-medical-device-reporting/how-enroll-emdrprogram under “Low Volume Enrollment Process” to complete the testing in order to obtain its Web Trader production account.
Your response dated September 17, 2018 did not address this deficiency.
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 #582516 when replying. If you have any questions about the contents of this letter, please contact Naomi Schwartz by telephone at 301-796-2645 or by e-mail at firstname.lastname@example.org.
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.
Timothy Stenzel, M.D., Ph.D.
OHT7: Office of Office of In Vitro Diagnostics and
Office of Product Evaluation and Quality
Center for Devices and Radiological Health