Inspections, Compliance, Enforcement, and Criminal Investigations
GaleMed Xiamen Co., Ltd. 4/23/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
APR 23, 2014
VIA UNITED PARCEL SERVICE
I-Lan 268, Taiwan
Dear Mr. Lee:
During an inspection of your firm located in Xiamen, China, on December 9, 2013, through December 12, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures manual emergency ventilators, manual resuscitators, positive end expiratory pressure breathing attachments, and continuous facility use ventilators. 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.
Our inspection 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. We received a response from Enhe Liu, Quality Assurance Director, dated December 20, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. Significant violations include, but are not limited to, the following:
1. Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17.
For example, during the inspection at your firm, it acknowledged that it did not have a written MDR procedure.
We reviewed your firm’s response and conclude that it is not adequate. Your firm developed a written MDR procedure titled, (b)(4), dated 12-25-2013. The following issues were noted:
a. Your firm’s MDR 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. For example, the procedure omits the definition from 21 CFR 803.3 of the term “become aware,” and definitions of the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1). The exclusion of the definitions for these terms 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. Your firm’s MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, instructions for how to obtain and complete the FDA 3500A form are not addressed.
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/ForIndustry/FDAeSubmitter/ucm107903.htm
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.
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.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action that include requirements to employ appropriate statistical methodology where necessary to detect recurring quality problems, as required by 21 CFR 820.100(a)(1).
For example, your firm’s Corrective and Preventive Action (CAPA) procedure, (b)(4) does not include a requirement for analyzing quality data using appropriate statistical methodology to detect reoccurring quality problems. Your firm has yet to initiate any CAPAs based on the results from data analysis, such as trending.
Your firm’s response to this observation appears to be adequate.
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints to determine whether the complaints represent events that are required to be reported to FDA under 21 CFR 803, Medical Device Reporting, as required by 21 CFR 820.198(a)(3).
For example, your firm’s Customer Complaint Procedure, Document (b)(4), does not require complaints to be evaluated to determine whether they should be filed as a Medical Device Report (MDR). A total of 21 complaints were reviewed and none of them were evaluated by your firm to determine if an MDR should be filed.
Your firm’s response to this observation appears to be adequate.
3. 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 21 CFR 820, as required by 21 CFR 820.184.
For example, your firm has not established a DHR procedure.
We reviewed your firm’s response and conclude that it is not adequate. Your firm has updated Quality Records, Documents’#: (b)(4), with adequate DHR requirements; however, your firm did not provide training records for the new DHR procedure. Labeling has been added to the three DHRs specifically mentioned in the FDA-483 (b)(4), #(b)(4), and #(b)(4). However, your firm has not considered retrospectively adding labeling to other incomplete DHRs.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Room 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #420390when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Branch Chief, Foreign Enforcement Branch at (301) 796-5587or fax (301) 847-8139.
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.
Steven D. Silverman
Office of Compliance
Center for Devices and
Cc: Cheng Chun Yeh
GaleMed Xiamen Co., Ltd.
Amoy Export Processing Zone
39, Section 3, Haijing East Road
Xiamen, Fujian 361-026, China