VIA UNITED PARCEL SERVICE
MAR 29, 2017
Chairman and Owner
Hebei Pukang Medical Instruments Co., Ltd.
Dongshiduan Town, Xushui County
072550 Baoding, Heibei
Dear Mr. Shuxun Bai:
During an inspection of your firm located in Boading, Heibi, Chinaon January 9, 2017, through January 12, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures AC-powered adjustable beds, wheeled stretchers, manual beds, cabinet trays, and operating room table and attachments. 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.These violations include, but are not limited to, the following:
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
1. Failure to establish and maintain 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 does not have a written design control procedure. Your firm manufactures AC-powered adjustable hospital beds, including models DA-21, B-45, DA-9, DA-1, and B-48, which were not subjected to any design control process.
2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm has not established a procedure for implementing corrective and preventive action.
3. Failure to 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 has not validated the (b)(4) of the AC-powered adjustable hospital bed frames. This includes (b)(4).
4. Failure to establish and maintain procedures to ensure that device history records (DHR’s) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of this part, as required by 21 CFR 820.184. For example, your firm does not maintain DHRs for the AC-powered adjustable hospital beds, including models five-function electric bed (DA-2-1), multi-function obstetric bed (B-45), five-function electric bed (DA-9), five-function electric bed (DA-1), and obstetric electric bed (B-48).
5. Failure to maintain complaint files and 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 disposed procedure, document #ZJ06, does not require evaluation of complaints to determine if they should be filed as Medical Device Reports (MDR). Also, your firm is not following its procedures to evaluate and investigate complaints. Twenty-four of twenty-six complaints from 2014 through 2015 that involved product defects were not evaluated and investigated as required in your firm’s complaint disposed procedure, ZJ06.
6. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c). For example, your firm has not established a management review procedure or conducted a management review.
7. 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. These quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. For example, your firm has not established a procedure for quality audits or conducted a quality audit.
Our inspection also revealed that your firm’s AC-powered adjustable beds, wheeled stretchers, manual beds, cabinet trays, and operating room table and attachment 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:
8. Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm does not have a MDR procedure.
Given the serious nature of the violations of the Act, devices including AC-powered adjustable beds, wheeled stretchers, manual beds, cabinet trays, and operating room table and attachments, manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, 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 (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.
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, Rm 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case # 518493 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Branch Chief, Foreign Enforcement Branch at firstname.lastname@example.org (e-mail) or +1-240-402-4020.
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.
CAPT Sean M. Boyd, MPH, USPHS
Deputy Director for Regulatory Affairs
Office of Compliance
Center for Devices and Radiological Health
144 Research Drive
Hampton, VA 23666