Qianjiang Kingphar Medical Material Co Ltd.

During an inspection of your firm located in Qianjiang, China from June 30, 2025, through July 3, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical masks, wound dressings, sterilization wraps, and surgical drapes. 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 Wang Jun, General Manager, dated July 21, 2025, 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 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).

Specifically, your firm conducts manufacturing and packaging operations in ISO 8 cleanrooms and has failed to develop adequate cleaning and inspection procedures for floors, walls, and surfaces in their Packaging Clean Room (Sterile Barrier Sealing) and in their Woven Gauze Clean Room (Automated Cutting/Folding) to prevent uncontrollable contamination. For example:

a. The investigator observed structural issues in which floor molding is pulling away from the wall and ceiling molding deficiencies that do not allow for effective cleaning to prevent contamination of product(s).

b. The investigator observed and documented dirt and filth accumulation on walls and floors in multiple areas with focal areas of concentrated filth especially under chairs, carts, machines, and any area where floor tape was used post cleaning.

c. The investigator noted that your firm’s Weekly Quality Department Inspection Sheet and the Daily Log Sheet for Clean Room Disinfection are not accurate as these documents state that walls, floors, ceilings, and lighting fixtures were clean; however, the investigator observed dirt in multiple areas in the clean rooms.

This is a repeat observation from your previous 2013 FDA inspection.

We reviewed your firm’s response and concluded that it is not adequate. CDRH acknowledges that your firm’s response states your firm’s Quality manager revised and improved the "Cleanliness Procedure for Clean Areas" (Q/Y014-15), formulated the cleaning methods and frequency for tape stains, and organized all cleaning workers, quality inspectors, and workshop supervisors to conduct training on the revised documents. Additionally, your firm provided a training record that states that this training record is for ‘Cleanroom cleaning instruction’ and a revised inspection check list that includes tape residue removal. However, your firm did not submit the following:

i. Revised "Cleanliness Procedure for Clean Areas" (Q/Y014-15);

ii. Procedure for the training of "Cleanliness Procedure for Clean Areas" (Q/Y014-15);

iii. Procedure for conducting environmental inspections to include identification of structural issues and corrective actions;

iv. Procedure for the environmental inspection training; and,

v. Retrospective review to identify whether the inadequate contamination controls have had an adverse impact on previously manufactured product(s).

The Agency remains concerned with your firm’s ability to adequately identify potential environmental excursions within your controlled cleanroom environments or to mitigate subsequent product contamination events resulting from cleanroom contamination.

2. Failure to establish and maintain procedures to adequately control environmental conditions, which could reasonably be expected to have an adverse effect on product quality and periodically inspect the environmental control system to verify that the system, including necessary equipment, is adequate and functioning properly, as required by 21 CFR 820.70(c).

For example: Your firm has not developed alert/warning limits for non-viable and viable (microbial) particle count levels based on historical performance data to demonstrate adequate environmental control of your ISO 8 clean rooms per ISO 14644-2, Cleanrooms and associated controlled environments- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by air particle concentration, which was referenced in your Environment microbiological inspection instruction document. Additionally, your firm’s procedures were not clear regarding the handling of excursions of non-viable and viable particle count limits and gave the example that there were no “breach handling provisions” in the Environmental Controls Procedures or Microbiological Testing Procedures.

We reviewed your firm's response and concluded that the adequacy cannot be determined at this time. CDRH acknowledges that your firm’s response states that "Environmental Microbial Testing and Control Work Instruction” (Q/QY026-2) has been revised to include the alert/warning level and action level standards for suspended particles based on historical data and training was conducted. However, you did not include a report that analyzes and determines these levels, and your firm did not conduct a retrospective review of data against these alert/warning levels. Additionally, the revised procedure does not include your firm’s analysis, and it does not include investigation actions when an excursion occurs.

Other federal agencies may take your compliance with the FD&C Act and its implementation regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.

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 address 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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Stephen Anisko at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case #716715” when replying. If you have any questions about the contents of this letter, please contact: Claire Briglia at Claire.Briglia@fda.hhs.gov.

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 any violations and take prompt actions to address any violations and bring the products into compliance.