Hubei Weikang Protective Products Co., Ltd. 8/12/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
August 12, 2013
VIA UNITED PARCEL SERVICE
Mr. Xiangwu Yang
Hubei Weikang Protective Products Co., Ltd.
GongQing Chuang Ye Garden, Yewand Road
Xiantao City, Hubei, 433000, China
Dear Mr. Yang:
During an inspection of your firm located in Xiantao City, Hubei, China, on April 1, 2013, through April 4, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical masks. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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.
Your firm’s response, dated July 16, 2013, to the Form FDA 483 (FDA 483), List of Inspectional Observations, was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. This response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter.
We received a response from Ms. Guanghua Han, General Manager, dated April 25, 2013, concerning our investigator’s observations noted on the FDA 483 that 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, as required by 21 CFR 820.100(a). For example:
A. Your firm’s Corrective and Preventative Action Procedure, WK/QR-0-13, is not adequate. Your firm’s procedure states that investigations are to be conducted if non-conformances are (b)(4) per (b)(4). Your firm, however, does not collect non-conformance data by (b)(4), to determine if the nonconformance rate has (b)(4).
B. Your firm’s Corrective and Preventative Action Procedure does not require verification or validation of corrective actions, nor does it require the implementation of corrective and preventative actions. For example, verification of corrective actions for the two CAPA’s generated since January 2012, was not conducted by your firm.
The adequacy of your firm’s response dated April 25, 2013, cannot be determined at this time. Your firm stated that, before the inspection, the nonconformance rate was calculated on the (b)(4) and could not be tracked to (b)(4). In response to the observation, your firm provided evidence of its updated Nonconformance Procedure, WK-QP-18. Your firm also provided training records for personnel on the revised procedure, as well as the new training records for use of the new forms. However, objective evidence was not provided to demonstrate that this corrective action was implemented. Also, your firm stated that the requirement for verification is documented in the CAPA procedure; however, without an English translation of the CAPA procedure, this could not be verified. Additionally, your firm indicated that a retrospective review is being conducted to address CAPAs without verification or validation of corrective actions. However your firm did not provide objective evidence that this requirement is being implemented.
2. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). For example:
Your firm did not provide documentation to indicate design transfer activities were performed.
The adequacy of your firm’s response dated April 25, 2013, cannot be determined at this time. During the inspection, your firm stated that it did not have design transfer procedures. In addition, your firm stated that it is developing a file of design transfer for (b)(4), which is expected to be completed in (b)(4). As evidence of its commitment, your firm provided: a copy of the latest version of product specifications and inspection criteria; the obsolete version of product specifications and inspection criteria effective at the time of the (b)(4); test reports per EN 14683 to support the claim on the product; and examples of the inspection reports of shipments inspected in 2009 through 2013, which are intended to demonstrate that the products at your firm are consistently meeting specifications required by the customer. Additionally, your firm stated that it is developing a standard operation procedure to handle design transfer. Your firm stated that the SOP is in development and, therefore has not provided a copy for the agency’s review.
3. Failure to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example:
The labeling on your firm’s surgical masks states that the devices meet international standard EN 14683 Type I or Type II; however, your firm does not have documentation that the devices conform to the standard. Additionally, your firm manufactures its own (b)(4) without a procedure that provides specifications for time, temperature, pressure, speed, line clearance, allowable percentage of (b)(4), or percentage and type of (b)(4) allowed.
Your firm’s response to this observation appears to be adequate.
4. Failure to establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and the product or environment could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(d). For example:
The inspection revealed that procedures are not posted to indicate the proper way to gown and wash up before entering the production area to perform work duties. Additionally, the inspection revealed that there is no hand soap in the wash rooms, or a means for employees to dry their hands in a sanitary manner.
Your firm’s response to this observation appears to be adequate.
5. Failure to establish and maintain procedures to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning and use, as required by 21 CFR 820.70(g). For example:
The inspection revealed that the (b)(4) equipment was left in an un-cleaned state after its last use, in that an (b)(4), miscellaneous debris and dust were noted in the (b)(4), and that (b)(4) and (b)(4) were left open to the environment.
The adequacy of your firm’s response dated April 25, 2013, cannot be determined at this time. Your firm provided evidence of its Cleaning Procedure, WK-QP-27, which it states was not implemented during the inspection. Your firm provided evidence of CAPA WK-QR-0-13, opened to address the issue, and training records for the employees in its production department. Additionally, your firm stated that it would verify the effectiveness of CAPA WK-QR-0-13, as required by your firm’s CAPA verification procedure.
Your firm has not provided evidence of the verification of effectiveness for CAPA WK-QR-0-13.
6. Failure to establish and maintain procedures to control product that does not conform to the specified requirements, as required by 21 CFR 820.90(a). For example:
Your firm’s Nonconformance Control Procedure WK-QP-18, does not include or refer to your firm’s supplemental document, which indicates that a nonconforming product investigation is performed if the reject rate is (b)(4). For nonconformance #WK/QR-0-40, dated 12/25/2012, there is no documentation of an investigation into the non-conformance to verify that the problem did not extend to similar (b)(4) machines and/or other lots manufactured on this (b)(4) machine. Regarding the (b)(4) with inadequately (b)(4), there is no documentation of the lot numbers involved, the size of the lot, the quantity of the defects found, the number re‑worked, or the number of rejects after re-work. Additionally, there is no record to indicate if the problem was due to lack of maintenance, or the need for employee re-training.
We reviewed your firm’s response and conclude that it is not adequate. While your firm stated that it has revised Nonconformance Control Procedure (WK-QP-18) to include the supplemental information (product investigation procedure) and that it has provided training records for its employees, your firm has not provided evidence of a retrospective review of its nonconforming product records for products manufactured on similar (b)(4) machines, as well as other lots manufactured on this particular (b)(4) machine.
7. Failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix-ups, as required by 21 CFR 820.60. For example:
The inspection revealed over (b)(4) rolls of non-woven material stored in your firm’s warehouse with no identification labels.
We reviewed your firm’s response and conclude that it is not adequate. Your firm has provided documentation that it has added a waste label to the (b)(4) rolls of unlabeled, nonwoven rolls and moved them to the waste area, updated its Warehouse Control Procedure, trained its employees on the new procedure, and determined that it needs to use a (b)(4). Your firm has not provided evidence that demonstrates it has conducted a retrospective review of all products at your facility to ensure that the products are identified properly according to the requirements of 21 CFR 820.60.
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. 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 #407844 when replying. If you have any questions about the contents of this letter, please contact: Carl Fischer, Branch Chief, General Hospital Devices Branch at 1-301-796-5771 (phone) or 1-301-847-8137 (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