- Xiantao Tongda Non-woven 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
NOV 25, 2015
VIA UNITED PARCEL SERVICE
Xu Chu Bing
Xiantao Tongda Non-Woven Products Co., Ltd
18 Pengchang Road
Dear Mr. Xu:
During an inspection of your firm, located at 18 Pengchang Road, Xiantao, China, on July 25, 2015, through July 26, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sterile surgical gowns and masks. 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. We received a response from Chao Xu, dated August 6, 2015, 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 procedures to control environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c). For example:
a) Your firm 's cleaning procedure, "Environmental and Sanitary Cleaning Control Procedure," (b)(4), Version A/0, requires (b)(4). However, your firm does not have controls to prevent contamination from (b)(4).
b) (b)(4) describes procedures for cleaning work areas, cleaning air conditioning filters, and documenting cleaning activities. However, your firm did not maintain documentation of cleaning activities. Additionally:
i. Floors throughout the facility were covered with trash, dirt, and debris, resulting in fabric and product exposure to dust and debris from the floor and open outer doorways. Rolls of material in the production and storage areas were observed to be soiled; and
ii. Holes in the tile flooring were filled with trash.
c) There were holes in the walls of (b)(4), exposing the interior work area to conditions outside of the building.
d) Doors in the warehouse and (b)(4) had holes in the middle and at the bottom. These doors are located on (b)(4) and open to the outside of the building, resulting in exposure of raw, in-process, and finished materials, to uncontrolled conditions.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states that repairs to the facility are in process and that a new facility is under construction, and that your firm has committed resources for the cleaning of floors in the production areas. However, your firm's response does not demonstrate how these initiated and promised corrections will prevent a recurrence of the violations; Your firm's response does not address how the proposed corrective actions will be verified as adequate and monitored to prevent future recurrence. Also, your firm's response does not include documentation of implementation of the corrective actions.
2. Failure to establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 CFR 820.150(a). For example:
a) Rolls of (b)(4) material used for surgical gown manufacturing were stored outside the building. ·
b) Gown components were stored on tables made of unfinished wood covered with soiled cardboard boxes.
c) Plastic bins used for storage of in-process and finished goods were not clean, and were observed to contain what appeared to be stagnant water.
d) Three rolls of material in use in the (b)(4) production area appeared to have large water stains and were soiled.
e) Inner and outer cartons for surgical masks and other products were stored directly on the floor and were adjacent to an open door to the exterior of the building.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response does not include an assessment to identify the causes contributing to stained and soiled fabric, as well as unclean storage bins, and the corrective and preventive actions needed to address this issue. Your firm's response does not address how the storage requirements for packaging materials would be implemented. Further, your firm's response does not address how the proposed corrective actions will be verified as adequate and monitored to prevent future recurrence. Your firm's response also, does not include documentation of implementation of the corrective actions.
3. Failure to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(e). For example, your firm's "Environmental and Sanitary Cleaning Control Procedure," (b)(4), Version A/0, specifies gowning requirements, and employee practices for the surgical mask and gown manufacturing environment as follows:
However, your firm has not implemented the procedure's requirements. For example, the following conditions were observed in your firm's production and office areas:
a) Employees wearing open-toed shoes and sandals in production areas. One employee in the (b)(4) production area was barefoot;
b) Employees not wearing face masks;
c) Nonoperational hand sink located at the entrance to the surgical mask production area; and
d) Employees not meeting the sanitizer hand dip requirement, following hand-washing.
Additionally, the following conditions were also observed in your firm's production and office areas:
e) Employees lacked appropriate gowning, specifically: employees were wearing shorts, short-sleeve shirts, and sleeveless shirts in the production area, resulting in bare-skin contact with isolation gowns during folding;
f) Nonoperational electric hand dryers were located next to hand sinks, and soiled cloth towels used for hand-drying were hanging on the rack next to the sink in the office area restroom; resulting in inappropriate employee hygiene in a controlled manufacturing area that requires hand contact with product.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response does not include an assessment of the potential impact of these deviations on previously distributed product. Your response also does not address how the new employee gowning requirements and employee restrictions would be implemented. Your firm's response does not address how the proposed corrective actions will be verified as effective and monitored to prevent future recurrence. Further, your firm's response does not include documentation of implementation of the corrective actions.
4. Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm's nonconforming procedure, "Defective Products," (b)(4), Version: A/0, requires defective nonconforming items generated during production to be labeled and stored in the (b)(4). However, defective surgical masks were observed being discarded into cardboard boxes under the production lines without labeling to identify the masks as nonconforming.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response does not include an analysis of production records to determine whether the inadequate control of nonconforming product resulted in distribution of nonconforming product. While your firm's response identifies corrective actions to address the noted nonconformity, your firm's response does not address how the proposed corrective actions will be verified as effective and monitored to prevent future recurrence. Further, your firm's response does not include documentation of implementation of the corrective actions.
5. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a). For example, your firm's calibration procedure, "Monitoring and Measurement Control," (b)(4), Version: A/0, requires instruments used for measurement and/or testing be identified and labeled with the calibration expiration date. However, (b)(4), areas did not contain labeling identifying the calibration status.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response does not include an assessment to identify all inspection, measuring and test equipment, including mechanical, automated or electronic inspection and test equipment requiring calibration. Your firm also did not assess whether there was any adverse effects on device quality for instruments used while out of calibration. Further, while your firm identified corrective actions to address the noted nonconformity, your response did not address how the proposed corrective actions will be verified as effective and monitored to prevent future recurrence. Lastly, your firm did not provide any documentation of implementation of the corrective actions.
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L.110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2015.
Therefore all of your firm 's devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
Your firm must complete the steps necessary to register your establishment as soon as possible. Please pay the annual registration user fee, as required by the FDA Safety and Innovation Act, then register your Xiantao establishment, and list the devices your firm is manufacturing there. Your firm can obtain information regarding how to pay the annual registration user fee at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarket.
Once your firm has paid the fee and obtained your Payment Identification Number and Payment Confirmation Number, please access the FDA Unified Registration and Listing System at http://www.access.fda.gov/oaa/
to submit your registration and listing information. Instructions regarding how to register your establishment can be found at: http://www.fda.gov/MedicaiDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/Registrationandlisting/ucm053185.htm#6
Given the serious nature of the violations of the Act, medical devices 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.
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 Ill 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 3523, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case# 483752 when replying. If you have any questions about the contents of this letter, please contact L T David Dar, Acting Chief, Foreign Enforcement Branch, at firstname.lastname@example.org (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 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.
CAPT Sean M. Boyd, MPH, USPHS
Office of Compliance
Center for Devices and Radiological Health