Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
JUN 18 2012
VIA UNITED PARCEL SERVICE
Raymond K. L. Poon
Foshan R. Poon Medical Products Co. , Ltd
New City District, Danzao, Nanhai
Foshan 528-216, China
Dear Mr. Poon:
During an inspection of your firm located in Foshan 528-216, China, on February 7, 2012, through February 10, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures various non-sterile devices including: bedpans, crutches, walkers, canes, wheel chairs, and semi-electric hospital beds. 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 the semi-electric hospital beds 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 February 25, 2012, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional 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 adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
A. Your firm's ''Management Procedures of Corrective and Preventive Measures, Document #NLR-QP-27, Revision C/0," does not include a ·requirement for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, nor does it include a requirement to document the corrective and preventive action showing implementation.
B. The investigator reviewed twelve Corrective and Preventive Actions (CAPAs) from 2011 and found that all twelve CAPAs lacked verification or validation prior to implementation and failed to contain or refer to documented evidence showing that the proposed corrective/preventive actions were implemented.
C. Your firm's data analysis procedure, ''Data Analysis Management Procedure, Document #NLR-QP-26, Revision C/0," is not complete because it only requires non-conforming products and customer satisfaction surveys to be analyzed. No other quality sources of data (e.g., complaints, medical device reports (MDRs), and internal/external audit results) were identified and required to be analyzed.
We reviewed your firm's response and conclude that it is not adequate. While your firm provided evidence of its updated procedure, there is no evidence of a systemic corrective action, implementation of procedure, or training on either of the updated procedures.
2. Failure to adequately ensure that, when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example:
Your firm's process validation procedure, ''Special Process Management Procedures," requires that the (b)(4) process be validated. However, your firm has not validated the (b)(4) used to (b)(4) wheelchair and hospital bed metal frames.
We reviewed your firm's response and conclude that it is not adequate. While your firm provided a revised version of its "Special Process Management Procedures," no validation reports for the (b)(4) process were provided, nor has your firm provided an analysis of any other special processes requiring validation. Additionally, there is no evidence of implementation or training on the revised procedure.
3. 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). For example:
Your firm did not establish its design control procedures, "Document# NLR-QP-36," until December, 2011, although your firm began manufacturing the semi-electric beds in May, 2010, and shipping the devices to the United States the same year. The semi-electric beds were not subjected to a design control process. Additionally, the design control procedures have not been implemented.
We reviewed your firm's response and conclude that it is not adequate. While your firm provided its Design and Development Control Procedure, "Document# NLR-QP-36," your firm did not provide a systemic corrective action that would assess the design activities for all product lines. Also, your firm did not provide evidence of implementation of the procedure or training of employees on the procedure.
4. 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:
A. During the inspection, a total of twenty complaint files from January 2011, to January 2012, were reviewed. Eighteen of the twenty complaint files lacked the following: the original complaint, the facility/distributor MEDWATCH form, and the feedback to the customer. You told the investigator that you were not aware that your firm is required to maintain all documentation pertaining to complaints in the complaint file.
B. Of the twenty complaints reviewed during the inspection, the investigator found that your firm had submitted eighteen complaints to FDA as MDR reportable events. However, all eighteen complaints lacked documented evidence of evaluations and investigations.
We reviewed your firm's response and conclude that it is not adequate. Your firm has stated that all issues with complaint handling should be mitigated by the implementation of the revised "Customer Complaint Handling Procedures,'' to include the delegation of the task to record external feedback to the Sales department; investigating and analyzing problems; and correcting and preventing problems that meet CAPA conditions according to the procedure. However, the following were not provided: evidence of a retrospective review having been performed and evidence to document the implementation of training on the revised "Customer Complaint Handling Procedures."
Our inspection also revealed that the powered wheelchairs are adulterated under section 501 (f)(1)(B) of the Act, 21 U.S.C. § 351 (f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81 (b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicaiDevices/DeviceRegulationandGuidance/HowtoMarketYour Device/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
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. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices 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 (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 #308379 when replying. If you have any questions about the contents of this letter, please contact: Carl Fischer at 301-796-5770.
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 lnspectional 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