- Mooncup 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
MAY 27, 2016
VIA UNITED PARCEL SERVICE
Vantage Point, New England Road
Dear Ms. Hardy:
During an inspection of your firm located in Brighton, United Kingdom, on January 25, 2016, through January 27, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures menstrual cups. 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 you dated February 12, 2016, 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.
Your firm’s responses dated March 3, 2016 and March 31, 2016, to the Form FDA 483 (FDA 483) were not reviewed because they were not received within fifteen business days of issuance of the FDA 483. These responses will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm did not have design control procedures in place at the time the MCUK menstrual cup was designed and developed in 2002.
Additionally, your firm did not maintain a design history file (DHF) for the MCUK menstrual cup that contains or references records necessary to demonstrate that the design was developed according to the requirements outlined in 21 CFR 820.30. Your firm did not define design inputs and outputs; did not perform design reviews and design verification activities; did not validate the cleaning process to ensure the cleaning methods described in the Instructions for Use (IFU) are adequate; and did not verify/validate design changes prior to implementation.
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated it will establish design control procedures by May 31, 2016, conduct training by June 30, 2016, and establish the DHF for the MCUK menstrual cup according to the new design control procedures by July 29, 2016. Although your firm stated that no design related activities will occur until the new design control procedure is fully written and implemented, it is unclear if your firm plans to evaluate the existing design of the MCUK menstrual cup according to the new design control requirements.
Our inspection also revealed that the menstrual cupsare 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, the following:
2. Failure to report to FDA no later than 30 calendar days after the day your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a serious injury, as required by21 CFR 803.50(a)(1). For example:
a. Information in the complaint files for Note to File 510(k) IUD/01, signed May 5, 2013, describes a patient’s intrauterine device (IUD) being dislodged following removal of the Mooncup device, and the patient experienced an ectopic pregnancy and ruptured Fallopian tube, requiring surgical intervention; and
b. Information in the complaint files for Note to File 510(k) TSS/01, signed April 11, 2013, describes a patient developing Toxic Shock Syndrome (TSS) and testing positive for Staphylococcus Aureus, requiring removal of the patient’s IUD, and 18-day antibiotic therapy.
These serious injury events occurred with use of your firm’s device and should have been reported to FDA within 30 calendar days after becoming aware of such events.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not include evidence that these events were reported to FDA as MDRs.
3. Your firm included a revised MDR procedure titled “Medical Device Reporting and Correction Removal Procedure,” (b)(4), dated February 10, 2016. After reviewing your firm’s revised MDR procedure, the following issues were noted:
a. Your firm’s MDR procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
i. The procedure omits definitions for the terms “become aware,” “caused or contributed,” and “malfunction,” from 21 CFR Part 803.3, and the definition for the term “reasonably suggests,” found in 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
ii. The procedure does not reference a process for identifying and evaluating events occurring outside the U.S. as potentially reportable to FDA. If an event occurs in a foreign country, it may be reportable under the MDR regulation if the event involves a device that is the same or similar to a device that has been cleared or approved for marketing in the U.S. By not considering events that occur outside of the U.S., potentially reportable MDRs may not be identified and evaluated for MDR decision making and submission to FDA, as required by 21 CFR 803.50 and 21 CFR 803.53.
b. Your firm’s MDR procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example, there are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
c. Your firm’s MDR procedure does not establish internal systems that provide for timely transmission of complete MDRs. Specifically, the circumstances under which your firm must submit supplemental or follow-up reports and the requirements for such reports are not addressed.
d. Your firm’s MDR procedure does not describe how it will address documentation and record-keeping requirements, including:
i. Documentation of adverse event related information maintained as MDR event files.
ii. Information that was evaluated to determine if an event was reportable.
iii. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
iv. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
Given the serious nature of the violations of the Act, the devices manufactured by your firm, including the menstrual cups, 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 III 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, Room 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Refer to CMS case #495541 when replying. If you have any questions about the contents of this letter, please contact Daniel Walter, Chief, Foreign Enforcement Branch, at email@example.com (email), +1(240) 402-4020 (telephone), or +1(301) 847-8138 (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.
Robin W. Newman
Office of Compliance
Center for Devices and
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton, Colorado 80127