WARNING LETTER
Tenderneeds Fertility LLC
MARCS-CMS 603383 —
April 13, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Nancy S. McCormick
Recipient Title
President
Tenderneeds Fertility LLC
10162 Bradford Road
Greenville
,
IN
47124
United States
Issuing Office:
Division of Medical Device and Radiological Health Operations East
United States
WARNING LETTER
CMS # 603383
April 13, 2020
Dear Ms. McCormick,
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s device operations at Tenderneeds Fertility, LLC, located at 10162 Bradford Road, Greenville, IN 47124, from December 9 to 13, 2019. During the inspection, FDA investigators determined that your firm is an initial importer of devices and a manufacturer of several types of Intrauterine Insemination (IUI) and Intracervical Insemination (ICI) kits. Generally, your firm’s IUI and ICI kits include, but are not limited to, one or more devices packaged together and are intended for use during at-home insemination. 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 any function of the body.
Device Violations
Our inspection revealed that the IUI and ICI kits are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The IUI and ICI kits are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). 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 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your devices 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 products may be legally marketed.
Your IUI kits are also misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that the labeling for the devices fail to bear adequate directions for the purposes for which they are intended, and the kits do not meet the requirements for an exemption from section 502(f)(1) of the Act under 21 CFR 801 subpart D. For example, our inspection and review of your firm’s website (https://tenderneedsfertility.com)
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revealed that your IUI kits, including the “Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium,” are intended for home use and include an assisted reproduction catheter (“insemination device with syringe”). Generic devices classified under 21 CFR 884.6110, Assisted Reproduction Catheters are class II, prescription devices that require premarket clearance (510(k)) prior to marketing. To date, we are not aware of the clearance or approval of an assisted reproduction catheter or kit containing such catheter for home use. We remind you that inclusion of a prescription device in your IUI kit renders the entire kit a prescription device. Your IUI kits, were they cleared or approved, would be required to be sold as prescription devices and, therefore, must also comply with the requirements in 21 CFR 801.109.
21 CFR 801.109 requires that your IUI kits, as prescription devices, be “sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice” [21 CFR 801.109(a)(2)]; the label of each IUI kit must bear the symbol statement (i.e.,"Rx only" or "[rx] only") or “Caution: Federal law restricts this device to sale by or on the order of a _____”, the blank to be filled with the word “physician”, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the state in which the practitioner practices to use or order the use of the device [21 CFR 801.109(b)(1)]; and the labeling on or within each IUI kit package must bear information for use, including, but not limited to, indications, effects, routes, methods, and precautions [21 CFR 801.109(c)]. The inspection and our review of your website revealed that the IUI kits are sold on your firm’s website and elsewhere without a prescription or other order from a licensed practitioner, and the IUI kits’ labels do not include a prescription statement as described above nor does the package include information for use. Improper use of IUI kits by laypeople at home may raise serious public health and safety risks, including infections, injury to the vagina, uterine perforations, and risks if unwashed semen is delivered to the uterine cavity (e.g., severe uterine cramping/pain).
The inspection and our subsequent website review also revealed that the IUI kits and the pregnancy and ovulation tests that your firm markets are misbranded within the meaning of section 502(a)(1), 21 U.S.C. § 352(a)(1), in that the labeling for the devices is false or misleading. For example:
Your firm purchased products intended for use in animal insemination and resold the same products as device components in your firm’s IUI kits intended for use in human intrauterine insemination.
• Based on evidence collected during the inspection, your firm sold one “2 X Sterile
Human
Home Artificial Insemination Semen Kit” (emphasis added), an IUI kit, in December 2019. According to statements that you made during the inspection and the affidavit you signed during the inspection, you purchased the component devices included in your 2 X Sterile Human Home Artificial Insemination Semen Kits on
(b)(4)
, where they were advertised as “
(b)(4)
.” Based on statements that you made during the inspection, you did not inform the customer that these component devices included in the kit were only intended for use in animals. Use of the word “human” in the title of the kit may have created the misleading impression that the component devices were intended for use in humans and were appropriately manufactured for such use. In addition, human users of devices intended solely for animals may put the user at risk for infection due to microbial contamination or allergic reaction, irritation, or toxicity to cells due to inappropriate material biocompatibility.
• Although the 2 X Sterile Human Home Artificial Insemination Semen Kit referenced above was not sold on your website, we note that at numerous places on your website, you include the statement that certain individual products are “intended for human use, unlike many of our competitors whom [sic] only pass veterinarian use devices for women to use.” Including these statements in product descriptions may misleadingly suggest that you do not engage in the practice of representing that veterinarian devices are human devices. As described above, evidence collected during the inspection demonstrates that you do engage in this practice for certain products.
Your firm markets pregnancy and ovulation tests as part of certain of its IUI and ICI kits as well as individually. FDA has not approved your firm’s pregnancy or ovulation tests. Numerous representations on your firm’s website create the misleading impression of official approval of the pregnancy and ovulation tests. For example:
• The “Premium At Home Human Pro Series Insemination Kit” includes TenderNeeds “Fertility® LH Ovulation Test Strips (Qty 5)” and “TenderNeeds Fertility®HCG Pregnancy Test Strips (Qty 3)”. The product description states that “All test strips are FDA approved and over 99% accurate.”
• The “Tenderneeds Fertility HCG Pregnancy and LH Ovulation Urine Serum Combo Test Compare to First Response” description states that “All test strips are FDA approved and over 99% accurate.”
In addition, your pregnancy and ovulation tests are misbranded within the meaning of section 502(a) of the Act, 21 U.S.C. § 352(a), because you include the FDA logo on the tests’ boxes. The FDA logo is for the official use of the FDA and not for use on private sector materials. Such use may send a misleading message that FDA favors or endorses your products, or create a misleading impression of official approval of your devices. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.
The inspection also revealed that your devices are misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), 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), 21 U.S.C. § 360(j).
The inspection also revealed that your 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 21 CFR part 820. To date, we have not received a response from you, concerning our investigators’ observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued on December 13, 2019. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for design control as required by 21 CFR 820.30(a).
• Your firm has no design control procedures in place to control the design of devices. From November 10 to December 10, 2019, your firm distributed
(b)(4)
insemination kits for home use which were not developed under any design control.
You have not provided a written response to this observation; therefore, we are unable to evaluate any planned corrective actions that you may be considering or timetable(s) for implementation.
2. Failure to establish and maintain a design history file (DHF) for each type of device as required by 21 CFR 820.30(j).
• Your firm has no DHFs in place, which includes lack of a design and development plan; design inputs and outputs; design reviews; design verification; design validation; and design transfer for the IUI and ICI kits.
You have not provided a written response to this observation; therefore, we are unable to evaluate any planned corrective actions that you may be considering or timetable(s) for implementation.
3. 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).
• Your firm has no complaint procedure in place to receive, review, and evaluate complaints. During the inspection, the investigators requested copies of complaints received by your firm since January 2016. Your firm was only able to supply 38 emails of complaints since November 13, 2017, of which none were evaluated to determine whether the complaint represented an event which is required to be reported to FDA under 21 CFR part 803 or whether an investigation was necessary under 21 CFR 820.198(b).
You have not provided a written response to this observation; therefore, we are unable to evaluate any planned corrective actions that you may be considering or timetable(s) for implementation.
4. 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.
• Your firm lacks procedures to ensure all purchased or otherwise received devices conform to specified requirements, has not identified requirements for purchased devices, and has not evaluated suppliers against defined requirements. Since 2016, your firm imported and domestically procured finished devices, such as the component devices assembled as part of the IUI and ICI kits, from on-line e-commerce websites without documented evaluation that these suppliers were meeting any specified requirements (e.g., sterility assurance, inclusion of expiration dates), including quality requirements.
You have not provided a written response to this observation; therefore, we are unable to evaluate any planned corrective actions that you may be considering or timetable(s) for implementation.
5. Failure to establish and maintain procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90.
• Your firm has no procedures in place to control products that do not conform to specified requirements. Since 2016, your firm imported and domestically procured finished devices, such as the component devices assembled as part of the IUI and ICI kits, from on-line e-commerce websites without methods to control product by preventing distribution of devices to end users if the devices were found not to conform to specified requirements.
You have not provided a written response to this observation; therefore, we are unable to evaluate any planned corrective actions that you may be considering or timetable(s) for implementation.
6. Failure to establish and maintain procedures for implementing corrective and preventative action (CAPA) as required by 21 CFR 820.100(a).
• Your firm has no corrective and preventive action procedures in place to correct and prevent recurrence of identified existing and potential causes of nonconforming product and other quality problems.
You have not provided a written response to this observation; therefore, we are unable to evaluate any planned corrective actions that you may be considering or timetable(s) for implementation.
The inspection also revealed your devices are 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 (MDR). These violations include, but are not limited to:
7. Failure to develop, maintain, and implement written MDR procedures pursuant to the requirements of 21 CFR 803.17. For example, you do not have a documented procedure to evaluate information to determine if an event is a reportable event as required by 21 CFR 803.17.
Your firm should take prompt action to correct the device and other violations addressed in this letter. Failure to promptly correct these violations 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. 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 corrected. Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. More information on processes for persons denied a CFG can be found at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-fdas-decision-not-issue-certain-export-certificates-devices
. If you believe that your products are not in violation of the Act, please respond to FDA with your reasoning and any supporting information for our consideration.
Human Cell, Tissue, or Cellular or Tissue-Based Products Violations
At the time of FDA’s inspection, your establishment manufactured anonymous donor semen, which is a human cell, tissue, or cellular or tissue-based product (HCT/P).
During the inspection, FDA investigators also documented deviations from the regulations for HCT/Ps set forth in 21 CFR part 1271, and issued under the authority of section 361 of the Public Health Service Act [42 U.S.C. § 264].
The observations listed on the FDA 483 concerning these deviations were presented to and discussed with you at the conclusion of the inspection. The items of concern include, but are not limited to the following:
Failure to determine whether a donor is eligible as required by 21 CFR 1271.50 based upon the results of donor screening in accordance with 21 CFR 1271.75 and donor testing in accordance with 1271.80 and 1271.85. For example, from November 29, 2018, to December 6, 2019, you distributed
(b)(4)
units of anonymous semen to
(b)(4)
potential recipients. No required donor testing, donor screening, or donor eligibility determination was performed for the anonymous donor or the
(b)(4)
units of semen tested.
During the inspection, on December 10, 2019, you stated to the FDA investigators that you will cease manufacturing and distributing HCT/Ps. During the close out meeting, you stated to the FDA investigators that you no longer provide these services. Please confirm in writing that you do not intend to resume any HCT/P operations. If you do decide to resume any such operations, you must fully comply with all applicable requirements in 21 CFR part 1271, including but not limited to, registering with FDA as an HCT/P establishment, as set forth in 21 CFR 1271.21.
Additionally, FDA recommends notification of the
(b)(4)
recipients of the
(b)(4)
units of anonymous semen recovered from the donor for whom no required testing, required screening, or donor eligibility determination were performed that you failed to complete such testing, screening, or determination prior to providing the semen to the recipients.
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, 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 for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
We also request your attendance at a Regulatory Meeting to discuss the status of the specific steps you have taken since the inspection to correct the noted violations. We will host the meeting virtually on WebEx, on
May 5, 2020 from 9:30 AM to 11:00 AM Eastern Time
. This meeting will also allow you to ask any questions you may have and to provide FDA additional information regarding implementation of corrective actions. Please contact Sargum C. Morgan, Compliance Officer, at
313-393-8253
or by email at sargum.morgan@fda.hhs.gov for confirmation of the meeting date and time by April 21, 2020. A call-in phone number for the WebEx meeting will be provided at that time.
If you have questions regarding any issues in this letter, please contact Sargum C. Morgan, Compliance Officer, at
313-393-8253
or by email at sargum.morgan@fda.hhs.gov. Please send your reply electronically to Gina Brackett, Director of Compliance Branch, at oradevices1firmresponse@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 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/
Joseph Matrisciano, Jr.
Program Division Director
Office of Medical Device and Radiological Health
Division 1
/S/
Karlton Watson
Program Division Director
Office Biological Products Operations – Division 2
/S/
Benjamin R. Fisher; PhD
Director OHT3: Office of Office of Gastro-Renal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
_________________________
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Last accessed on April 9, 2020.
Content current as of:
04/21/2020
Regulated Product(s)
Medical Devices