Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm455778
Timestamp: 2019-02-24 04:53:45
Document Index: 524338088

Matched Legal Cases: ['§ 321', '§ 351', 'art 820', 'art 803', 'art 803', 'art 803', 'art 803']

Atom Medical Corporation 3/28/14
Mr. Kazuo Matsubara
3-1 8-15 Hongo Bunkyo-ku
Dear Mr. Matsubara:
During an inspection of your firm located in Saitama City, Japan, on September 17, 2013, through September 20, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures infant incubators, infant warmers, transport incubators, infusion pumps, infant resuscitation units, gynecological, and obstetrics equipment.
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 a response from Mr. Tsuyoshi Sugino, Regulatory Affairs Manager, dated October 3, 2013, 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 establish and maintain procedures to include requirements for identifying the actions needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3).
For example: Customer Complaints #66-0302, #66-1193, and #66-0401 for the product Dual lncu I were opened for similar serious situations described as: "electrical current leakage and malfunction; caused breaker to trip for NICU area." For these complaints involving neonatal incubators, your firm performed corrections by replacing the malfunctioning humidity chambers and sending letters to the complainants describing what your firm believed to be the cause of the problem. However, despite the repetition and seriousness of the failure, your firm did not consider actions to prevent the recurrence of nonconforming products.
We reviewed your firm's response and conclude that it is not adequate. Your firm updated its Quality Manual Section 8.5.1 (2) to clarify the corrective/preventive action requirements. However, your firm did not initiate preventive actions for the aforementioned complaints. Also, a retrospective review was not performed to ensure that all previous complaints were reviewed to ensure compliance with the corrective/preventive action requirements. Your firm did not provide training to employees to ensure that information on the procedural updates was adequately communicated.
For example: While the Atom Medical Corporation Quality Manual, Section 8.5.1 (2) mentions MDR requirements, the Complaint Procedure Regulations, AS-1402, which describes investigations of customer complaints, does not include steps to ensure that complaints are evaluated to determine whether the complaint represents an event that is required to be reported to FDA under 21 CFR Part 803. Additionally, the form used by your firm to document customer complaints does not demonstrate that complaints have been evaluated for MDR reportability.
We reviewed your firm's response and conclude that it is not adequate. Your firm updated its Quality Manual Section 8.5.1 (2) to clarify the MDR requirements. However, your firm did not update its Complaint Procedure Regulations to ensure that complaints are evaluated to determine whether the complaint represents an event that is required to be reported to FDA under 21 CFR Part 803. Your firm did not update its electronic complaint handling form to ensure documentation of whether or not complaints are evaluated for MDR reportability. Furthermore, a retrospective review was not performed to ensure that all previous complaints were reviewed to ensure compliance with MDR reportability requirements. Your firm did not provide training to employees to ensure information on the procedural updates was adequately communicated.
3. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 CFR 820.50(a)(1).
For example: On the "Approved Vendor/Outside Supplier List," your firm did not list its oxygen sensors vendor, for which no vendor evaluation file was available. Additionally, a supplier evaluation was not performed for your firm's listed supplier of humidity chambers (molded plastic parts) as required per your firm's procedures.
We reviewed your firm's response and conclude that it is not adequate. Your firm provided its audit report for the supplier of humidity chambers and the "Approved Vendor/Outside Supplier List" was updated to include its vendor for oxygen sensors. However, it was not clear if your supplier was evaluated as required since the list was only partially translated to English. Your firm did not provide evidence that it performed a retrospective review to ensure that all suppliers are listed in its "Approved Vendor/Outside Supplier List" and comply with its procedure "Vendor/Outside Supplier Control Regulations, AS- 0601." Your firm did not perform preventive action, such as training, to ensure continuing compliance with 21 CFR 820.50(a)(1).
4. Failure to identify by suitable means the acceptance status of product to indicate the conformance or nonconformance of product with acceptance criteria and to maintain the identification of acceptance status through the manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed, as required by 21 CFR 820.86.
For example: The Product Inspection Report for the Atom Infant Warmer Model103 (Infa Warmer I), Work Order Number L341800068, Serial Number 2341207, indicates the Power Supply (Voltage) was approved with a test result of "6033." However, the acceptance range for this test is "Not more than 700 VA +10% (770 VA or less)." Your firm stated that this was a typographical error that was not caught when the release was approved.
We reviewed your firm's response and conclude that it is not adequate. In response to this observation, your firm revised its "Product Inspection Report" by adding a column for the approver's verification. This change was incorporated to the procedure "Inspection/Test and Product Inspection/Test Regulation, AS-1001"; however, a copy of the updated version was not provided for review. Your firm stated that it would train its employees; however, training records were not provided for review. Your firm did not perform a retrospective review for similar deficiencies.
Our inspection also revealed that your firm's devices are misbranded under section 502(t)(2) of the Act 21 USC 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
Failure of your firm to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm's procedure titled "Quality Manual, Section 8, Measurement, analysis and improvement, Revision No. 5-0", dated August 1, 2013, it was determined that the referenced procedure is not an MDR procedure.
We reviewed your firm's response, dated October 3, 2013, and conclude that it is not adequate. Your firm submitted a revised procedure titled "Quality Manual, Section 8, Measurement, analysis and improvement," Revision No. 5-1. A review of the procedure was conducted and the following issues were noted:
1. Revision No. 5-1 does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
a. 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 of the terms "become aware," "caused or contributed," "malfunction," "MDR reportable event," and "serious injury," and definitions of the terms "reasonably known" and "reasonably suggests," found respectively in 21 CFR 803.50(b) and 803.20(c)(1), from the procedure 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).
b. The procedure does not reference a process for identifying and evaluating events occurring outside the U.S. as potentially reportable to FDA. For example, under Section 2, Reporting to Regulatory Authorities, the procedure limits your firm's reporting to FDA of incidents occurring in the U.S. If an event occurs in a foreign country, it may be reportable under the MDR regulation if the event involves a device that is the same or similar to a device that has been cleared or approved for marketing in the U.S. By not considering events that occur outside of the U.S., potentially reportable MDRs may not be identified and submitted to FDA as required by 21 CFR 803.50 and 21 CFR 803.53.
2. Revision No. 5-1 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. For example:
3. Revision No. 5-1 does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
b. The circumstances under which your firm must submit supplemental or follow-up reports and the requirements for such reports.
c. Although the procedure includes references to 30 day and 5 day reports, it does not specify calendar days and work days, respectively.
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL: http://www.fda.gov/Forlndustry/FDAeSubmitter/ucm107903.htm
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 lll 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 with in 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 Compliance, Field Operations Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 416134 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter at 301-796-5587 or 301-847-8128.
Mr. Tsuyoshi Sugino,
Mr. Rene van ae Zande
US AgentEmergo Group, Inc.