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WARNING LETTER

Baylab USA, LLC MARCS-CMS 679001 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Ashley Park, President
Recipient Title
Justin C. Lee, Vice President of Strategic Planning, Development, and Operations
Baylab USA, LLC

2230 Lyndon B Johnson Fwy, Ste. 100
Dallas, TX 75234-7331
United States

Issuing Office:
OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality

United States

Secondary Issuing Offices

Division of Medical Device and Radiological Health Operations West

United States

WARNING LETTER
CMS: 679001

June 27, 2024

Dear Ms. Park & Mr. Lee:

During an inspection of your firm located in Dallas, TX on January 24, 2024, to January 31, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer and distributor of the Class II BAYLAB 3-Ply Surgical Mask (BEACON I) (ASTM Level 3 Mask). Your firm also manufactures the ASTM Level 1 Baylab 3-Ply Earloop Face Mask (ASTM Level 1 Mask) and the KN95 Respirator. Information and records gathered prior to, during, and/or after the inspection, including information on your website, www.baylabusa.com, reflect that your products are intended for medical use and are to be worn to reduce potential exposure of the user to particulates, bacteria, and/or blood or body fluids. 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 diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body.

Unapproved Device Violations

Our inspection revealed that your ASTM Level 1 Mask and KN95 Respirator, and certain versions of your ASTM Level 3 Mask1, are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The ASTM Level 3 Mask is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the material and intended use without submitting a new premarket notification to FDA as required by section 510(k), 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(i)-(ii). The ASTM Level 1 Mask and KN95 respirator are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

1. Specifically, your ASTM Level 3 Mask in “bay blue” was cleared under 510(k) submission, K212302, for adult use. The Indications for Use (IFU) for the mask, as cleared under K212302 states, in part, that your mask is “intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material” and to “reduce the potential exposure to blood and body fluids.”

During the inspection it was revealed that your ASTM Level 3 Mask is offered in multiple colors and in pediatric sizes that were not included in your 510(k) submission. Additionally, a review of your firm’s website, http://www.baylabusa.com (last accessed June 21, 2024), revealed that your firm is marketing your ASTM Level 3 Mask in colors including “silver surf,” “admiral navy,” “orca black,” “seafoam green,” “sea lavender,” “coral pink,” and “white tide.” Your website also offers the “Kids ASTM Level 3 Mask,” “Anti-Fog ASTM Level 3 Mask,” as well as special edition models with printed logos including, but not limited to, “Breast Cancer Awareness,” “Love,” and “Summer” masks.

The additional colors, materials, and expansion of the user population constitute significant changes or modifications that require a premarket notification. For example, the introduction of new materials, including new colors (colorants) and printed logos, are changes or modifications that could significantly affect the safety or effectiveness of the device in that they may alter the chemistry of the final device. Colorants are known to contain pigments, dyes, additives and/or contaminants that may cause adverse effects such as irritation or allergic reactions, especially in very vulnerable pediatric populations. FDA would therefore expect to review additional testing, including biocompatibility testing, in a premarket submission to evaluate the impact of these changes. Furthermore, the change in the user population (i.e., the inclusion of a pediatric population) is a major change in the intended use of the device. FDA would expect to review additional performance data, including, but not limited to, mask fit as well as heavy metal and element analysis, to demonstrate that your mask can be used safely and provide the intended respiratory protection in the pediatric population. This information needs to be reviewed in a premarket submission as required by 21 CFR 878.4040 and 21 CFR 807.81.

2. Specifically, during the inspection, labeling was collected for your ASTM Level 1 Mask and KN95 Respirator. The labeling collected for the ASTM Level 1 Mask included statements claiming, “bacterial filtration efficiency,” “particle filtration efficiency,” and “fluid resistance,” and the label collected for the KN95 respirator contained a statement claiming, “filtration efficiency against solid and water-based particulates.” Additionally, a review of your firm’s website, http://www.baylabusa.com (last accessed June 21, 2024), revealed that both devices are marketed as providing at least 95% particulate or bacterial filtration efficiency and fluid resistance at 80 mmHg. Both devices are also stated to be “fluid resistant.” The masks are available for purchase on your website in various colors and with various logos. Based on these claims, these products are devices under 21 U.S.C. § 321(h) because they are intended for use in the diagnosis of diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body. The ASTM Level 1 Mask and the KN95 Respirator are therefore adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a).

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Adulteration under section 501(h) – Quality System Regulations

Our 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. These violations include, but are not limited to, the following:

1. Failure to establish and maintain design controls, as required by 21 CFR § 820.30(a). Specifically, although your Quality Management System Manual, Version III, Rev. 11/15/2023 briefly outlines some procedures for design controls (e.g., design planning, inputs, outputs, reviews, verification and validation, and changes), our inspection revealed that your firm has not adequately established and maintained all required design controls. For example, the Quality Management System Manual does not reference or discuss the establishment and maintenance of a design history file (DHF), as required by 21 CFR 820.30(j), and, upon request at the inspection, your firm could not provide a DHF. Further, our inspection revealed that your design was not validated under simulated or actual use conditions and no risk analysis was performed, as required by 21 CFR 820.30(g). Your firm has therefore failed to establish and maintain design controls for the ASTM Level 3 Mask.

2. Failure to establish and maintain requirements, including quality requirements, that must be met by suppliers, contractors, and consultants as required by 21 CFR § 820.50(a).

Specifically, although your Quality Management System Manual, Version III, Rev. 11/15/2023 briefly outlines Purchasing activities, e.g., purchasing process, purchasing information, and verification of purchased product, it does not reference supplier controls procedures or discuss supplier requirements or evaluation. You do not have documentation of evaluation of your suppliers, contractors, or consultants.

3. Failure to conduct quality 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, as required by 21 CFR § 820.22.

Specifically, although your Quality Management System Manual, Version III, Rev. 11/15/2023 briefly outlines Internal Audit activities, such as conducting internal audits at planned intervals, at the inspection you were unable to provide documentation that any audits had been conducted.

4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR § 820.198(a).

Specifically, your Quality Management System Manual, Version III, Rev. 11/15/2023 briefly outlines Monitoring and Measurement, Customer Satisfaction activities such as customer complaints, customer satisfaction and other feedback, and defining methods for collecting and analyzing pertinent information. However, you do not have a complete complaint handling procedures such as determining whether a complaint represents an event which is required to be reported to FDA under Part 803, Medical Device Reporting. We reviewed your complaint log from the period of August 2023 to January 2024. You stated that you did not have a system to track complaints prior to August 2023.

Observations Pertaining to Other Regulations

Misbranding under Section 502(c) for Failure to Have Compliant Labeling

The inspection revealed that your devices are misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of section 519 of the Act, 21 U.S.C. § 360i, to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a) – which was promulgated under authority of section 519 of the Act, among other provisions – requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. The labels of the Beacon I 3-Ply Earloop Face Mask (ASTM Level 3 Mask) devices do not bear such a UDI.

Specifically, the labels for Beacon I 3-Ply Earloop Face Mask (ASTM Level 3 Mask) do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, and there is no UDI presented in easily readable plain-text on the label of the device (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses automatic identification and data capture (AIDC) technology on the label of the device (see 21 CFR 801.40(a)(2)).

Misbranding under Section 502(t)(2) for Failure to Submit Required Information

In addition, the Beacon I 3-Ply Earloop Face Mask (ASTM Level 3 Mask) device is misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting this device. In particular, 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI. FDA has determined that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. Our inspection revealed that your firm designs the finished product label for your ASTM Level 3 Mask and final product labeling reflects your firm’s name, address, and website. Baylab USA, LLC is therefore a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting this device.

In addition, our inspection also revealed that your firm’s ASTM Level 3 Mask device is 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:

1. Failure to adequately develop, maintain, and implement written medical device reporting (MDR) procedures as required by 21 CFR 803.17.

Specifically, your Quality Management System Manual, Version III, Rev. 11/15/2023 does not reference MDR procedures. You do not have MDR procedures.

The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).

Our office requests that Baylab USA LLC cease any activities that result in the misbranding or adulteration of the ASTM Level 3 Mask, ASTM Level 1 Mask, and KN95 Respirator, such as the commercial distribution of the devices for the uses discussed above.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing 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. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as 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 and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe 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 e-mail to: Jessica Mu, Director of Compliance Branch at oradevices3firmresponse@fda.hhs.gov. Refer to CMS case # 679001 when replying. If you have questions regarding the content of this letter, please contact Compliance Officer, Raymond W. Brullo at 949-608-2918, or via email at raymond.brullo@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 the violations and take prompt actions to correct the violations and bring the products into compliance.

Sincerely,
/S/

Binita S. Ashar, MD, MBA, FACS.
Director
OHT4: Office of Surgical & Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

/S/

Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological Health
Division 3 West

__________________________

1 More specifically, only the “bay blue” ASTM level 3 Mask was cleared under 510(k) submission. The other colors and versions of the ASTM Level 3 Mask marketed by your firm were not cleared under the 510(k) submission.

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