Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
November 14, 2013
VIA UNITED PARCEL SERVICE
Chien Chia Yu (Leo)
Cheen Houng Enterprise Co., Ltd.
23 Alley 11, Lane 65, San Dreen St.
Taipei (Shulin), Taiwan
Dear Mr. Yu:
During an inspection of your firm located in Taipei (Shulin), Taiwan, on August 5, 2013, through August 8, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures disposable/reusable resuscitators, water traps, pediatric stretchers, and face cradles. 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. These violations include, but are not limited to, the following:
1. Failure toensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
For example, your firm did not adequately validate the (b)(4) used to manufacture critical components for the Y2000 disposable/reusable manual resuscitators. The validations for each of the critical components only consisted of a (b)(4). There was no assurance that the processes were validated with a high degree of assurance, were performed under approved protocols, included operational qualifications to establish a range of operating parameters, and included tolerance ranges for the established nominal operating parameters. Additionally, parameters settings, including any adjustments, were not documented for each production run.
2. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, quality data sources such as complaints and nonconformances were not formally reviewed by statistical means to identify existing and potential causes of nonconforming product or other quality problems. Additionally, objective evidence was not included or referenced in CAPAs to demonstrate that actions were identified to correct and prevent recurrence of nonconforming product or other quality problems.
3. Failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product and to document disposition of nonconforming product, as required by 21 CFR 820.90(b)(1).
For example, for nonconformance 100.12.8, (b)(4) pieces of the Y2000 disposable resuscitator were found to have (b)(4) issues. The final disposition of these nonconforming parts was not documented on nonconformance reports.
4. Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j).
For example, the DHF for the Y2000 disposable/reusable manual resuscitators is incomplete in that it does not include approval of design inputs and outputs; raw data from design verification; device identifications; methods; dates; and names of individuals performing verification testing of functional requirements.
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’s complaint procedure does not include or reference the criteria used to determine whether an event meets the requirement for medical device reportability. (b)(4) complaints were not evaluated for medical device reportability.
6. Failure to establish 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.
For example, your firm’s internal audit procedure requires audit schedules to be developed (b)(4) prior to execution of the internal audit. However, the audit schedules did not include dates for when the audit plan was developed and approved.
7. Failure to have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by 21 CFR 820 are correctly performed, as required by 21 CFR 820.25(a).
For example, regarding your firm’s internal audit procedure (QP-GM-06:Rev A1, Effective: June 1, 2003), the lead quality auditor who performed audits in (b)(4) and (b)(4) was not qualified to perform internal audits because the person that trained the auditor was not certified. .
8. Failure to maintain records of changes to documents to include a description of the change, identification of the affected documents, the signature of the approving individuals, the approval date, and when the change becomes effective, as required by 21 CFR 820.40(b).
For example, dates were crossed out on the (b)(4) audit plan without a signature and date.
The 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 actions (including any systemic corrective actions) 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.
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. 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #411274 when replying. If you have any questions about the contents of this letter, please contact Carl Fischer, Ph.D., at 301-796-5770 or 301-847-8137 (fax).
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