- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Medical Devices
Recipient NameFernando Lasso Génova
Recipient TitleChief Executive Officer
- Global Medical Technology SL
C/ Isla de Alegranza 2, Nave 51
28703 San Sebastian De Los Reyes Madrid
- Issuing Office:
- Center for Devices and Radiological Health
December 20, 2019
Dear Mr. Génova:
During an inspection of your firm located in San Sebastian De Los Reyes Madrid, Spain, on October 7, 2019 through October 10, 2019, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Platinum GMT IPL System Cloud. 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.
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 a response from you dated November 4, 2019, 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 the noted violations.
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, as required by 21 CFR 820.90(a). Specifically, your firm has not established procedures for the identification, documentation, evaluation (including determination of the need for an investigation), segregation, and disposition of nonconforming product. For example, records of nonconforming incoming products are not maintained.
2. 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). Specifically, the design history file for the Platinum GMT IPL System only includes a risk analysis record and design verification reports for the device. Your firm acknowledged that no other design records were established. Additionally, review of the design history file for the Platinum GMT IPL system revealed the following deficiencies:
a. No records were provided to demonstrate that the system has been validated to ensure that the systems conform to defined user needs and intended uses.
b. No records were provided to demonstrate that the system software has been validated. For example, the software includes an algorithm that automatically selects the treatment energy level parameters based on the patients’ characteristics (e.g., (b)(4)). However, no records were provided to demonstrate that this software function has been validated to ensure that correct parameters are set when delivering treatment to the patients.
c. The following records were not established: design plan, design inputs (e.g., light energy source, power output, pulse duration), and design reviews.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm has not established procedures for corrective and preventive action.
4. Failure to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a). Specifically, your firm has not established procedures to ensure that testing equipment is routinely calibrated. For example, your firm utilizes an OPHIR Light Energy Tester during final inspection of the Platinum GMT IPL systems. During the inspection, your firm stated that the (b)(4) is “very important” because it measures the level of energy emitted by the Platinum GMT IPL systems. According to the calibration sticker affixed to the (b)(4), this tester was calibrated in 2015 and calibration was due in 2016 and yearly thereafter. However, during the inspection, your firm acknowledged that the tester has not been calibrated since 2015. Without proper calibration, there is no assurance that the tester can produce valid results for the level of energy emitted by the Platinum GMT IPL systems.
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(a). For example, your firm has not established procedures for complaint handling. Your firm stated that it believes that complaint handling for devices sold in the U.S. should be the responsibility of the U.S. distributor, but your firm does not have a documented agreement with the US distributor stating that they are responsible for complaint handling. In addition, Complaint #844 reports a Platinum GMT IPL system that generated an error during capacitor charging. If this error occurs, the system stops working and does not start treatment. However, the complaint has been open since April 2, 2018, and does not include an evaluation to determine if an investigation is needed or to determine if the event needs to be reported as a Medical Device Report.
6. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm has not established procedures for evaluation of suppliers to ensure that suppliers meet specified quality requirements. For example, no records were provided to demonstrate that the following suppliers of components used in the manufacture of the Platinum GMT IPL, which were identified as critical components by your firm during the inspection, have been evaluated:
|Supplier Name||Supplied component|
7. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, your firm has not established procedures for acceptance of incoming product. In addition, no records were provided to demonstrate that the following critical components used in the manufacture of the Platinum GMT IPL system have been inspected, tested, or otherwise verified as conforming to specified requirements:
|Component Part #||Description||Date Received|
8. Failure to establish and maintain procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record and the requirements of the Quality System regulation, as required by 21 CFR 820.184. For example, a device history record was not maintained for the Platinum GMT IPL system with Serial Number (b)(4), which was shipped to the U.S. on August 27, 2018. Your firm started distribution of the Platinum GMT IPL to the U.S. in March 2017. Since then, your firm has shipped approximately (b)(4) systems to the U.S. However, during the inspection, your firm acknowledged that it has not established procedures to ensure that complete DHRs are maintained for each Platinum GMT IPL.
9. Failure to establish and maintain adequate procedures to control all documents that are required by the Quality System regulation, as required by 21 CFR 820.40. Specifically, your firm has not established procedures for control of documents. For example, procedures for the testing of the Platinum GMT IPL system (“(b)(4)”) do not include the date and signature of the individuals approving the document.
10. Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Specifically, your firm has not established procedures for quality audits, and quality audits have not been performed.
11. 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). Specifically, your firm has not established procedures for employee training, and training records are not maintained.
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:
12. Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. Specifically, during the inspection, your firm acknowledged that it has not established procedures for Medical Device Reporting.
We reviewed your firm’s response and conclude that it is not adequate. This response stated that your firm has decided to (b)(4). The response also stated that currently your firm is (b)(4). However, the response did not include any details on your firm’s proposed corrections and corrective actions, or evidence of implementation of the proposed corrections and corrective actions to allow FDA to evaluate the effectiveness of the changes.
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. 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.
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 # 598226 when replying. If you have any questions about the contents of this letter, please contact: Purva Pandya at 240-402-9979.
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.
Binita Ashar, M.D., M.B.A., F.A.C.S.
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Derliz David Diaz
3401 NW 72nd Ave Ste B Ste MID-1261-1
Miami, FL 33122