- Hubei Weikang Protective Products Co., Ltd.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
OCT 2, 2015
VIA UNITED PARCEL SERVICE
Hubei Weikang Protective Product Co. Ltd. (HWPPC)
GongQuin Chuang Ye Garden,
Xiantao City, Hubei, 433000
Dear Mr. Yang:
During an inspection of your firm located in Xiantao City, Hubei, China on June 1, 2015, through June 4, 2015, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical suits; conductive shoes and shoe covers; surgical apparel accessories; polyurethane pads with starch copolymer, glycerin, and surfactant nursing pads; non-surgical isolation gowns; surgical caps; scavenging masks; operating room shoe covers; surgical dresses. 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. A previous warning letter was issued on August 12, 2013 for violations in document controls, corrective and preventive action controls, nonconforming product controls and identification and traceability controls. We received a response from Cindy Jiang dated June 17, 2015, 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 for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, Customer Complaint# 140120 dated May 1, 2014, reports small balls of fluff in the received finished product. The documented resulting corrective action required (b)(4). However, your document “Clean Management Program,” (b)(4), did not include this method of cleaning as a requirement.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide documentation showing an internal audit of CAPAs, to ensure CAPAs meet procedures and Quality System requirements.
2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example,
a. Your firm did not qualify the component supplier of (b)(4), Section 4.3.
b. Your firm did not document the review and evaluation of the material source change for (b)(4) component.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide documentation showing that internal audits of component suppliers were performed to ensure they have met specified requirements.
Given the serious nature of the violations of the Act, surgical suits; conductive shoes and shoe covers; surgical apparel accessories; polyurethane pads with starch copolymer, glycerin, and surfactant nursing pads; non-surgical isolation gowns; surgical caps; scavenging masks; operating room shoe covers; surgical dresses, 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 responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
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 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. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
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 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Refer to CMS case # 478690 when replying. If you have any questions about the contents of this letter, please contact the Foreign Enforcement Branch Chief at email@example.com (email) or +1(240)402-4020 (telephone).
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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and
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