- LockDown Medical 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|
Silver Spring, MD 20993
SEPT 11, 2014
VIA UNITED PARCEL SERVICE
Mr. Andrew T. Hull
Chief Executive Officer/Owner
LockDown Medical Ltd.
16 The Oaks, Clews Road
Dear Mr. Hull:
During an inspection of your firm located in Redditch, Worcestershire, United Kingdom on June 2, 2014, through June 5, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Surgicraft LockDown Acromioclavicular Device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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.
Our inspection revealed that the Surgicraft LockDown Acromioclavicular 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 (MDR).
We received a response from Mr. Kevin Edwards, Managing Director, dated June 30, 2014, 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 report to us no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned, and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
For example, Complaints (b)(6) and (b)(6) describe events where your firm’s Surgicraft LockDown Acromioclavicular Device malfunctioned. This device is a long-term implant. The Preamble of the Final Rule for Medical Devices, Medical User Facility and Manufacturer Reporting, Certification, and Registration, 60 Fed. Reg. 63585 (Dec. 11, 1995), states that a malfunction of a long‑term implant is reportable to FDA. There is no information in the complaint files to justify why these malfunctions, were they to recur, would not be likely to cause or contribute to a reportable death or serious injury. Therefore, an MDR should have been submitted for each referenced complaint.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states that your firm would submit MDRs for Complaints (b)(6) and (b)(6) by June 30, 2014. FDA has not received the MDRs for the referenced complaints.
2. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
For example, after reviewing your firm’s procedure titled, “Incident Reporting Procedure,” SOP (b)(4), Issue No. (b)(4), which was collected during the inspection at your firm and referenced as your firm’s MDR procedure, the following issues were noted:
a. There is no evidence that your firm’s MDR procedure has been implemented. For example, there is no effective date for the procedure. The procedure is stamped “(b)(4),” dated August 24, 2012, and signed.
b. SOP (b)(4), Issue No. (b)(4), 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, there are missing definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 of the terms “become aware,” “caused or contributed,” “malfunction,” and “serious injury,” and the definition of the term “reasonably suggests,” found in 803.20(c)(1), 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).
c. SOP (b)(4), Issue No. (b)(4), 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:
i. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
ii. The procedure, as written, does not specify who makes the decision for reporting events to FDA.
iii. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
d. SOP (b)(4), Issue No. (b)(4), does not establish internal systems that provide for timely transmission of complete MDRs. Specifically, the following are not addressed:
i. Instructions for how to obtain and complete the FDA 3500A form;
ii. The circumstances under which your firm must submit (initial 30 day, supplemental or follow-up, 5 day) reports and the requirements for those reports.
e. SOP (b)(4), Issue No. (b)(4), does not describe how your firm 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; and
iv. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
Your firm’s procedure includes references to baseline reports. Baseline reports are no longer required and we recommend that all references to Baseline reports be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
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
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 awarding of contracts.
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. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act, 21 U.S.C. § 351(h), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control all documents that are required by this part, as required by 21 CFR 820.40.
For example, your firm failed to implement its “Documentation/Data Control & Change Procedure,” SOP (b)(4), in that the Design History File for the Surgicraft LockDown Acromioclavicular Device was not adequately reviewed to ensure information accuracy. Consequently, an inaccurate revision of the device’s Instructions for Use (IFU) was reviewed, approved, and released for use since 2011 in the United States. The IFU did not contain information regarding the device’s risk profile. (b)(4).
The adequacy of your firm’s response cannot be determined at this time. Your firm indicated that it will review and update document control procedures to ensure that the process of reviewing and checking labeling against current specified requirements is clearly defined. Your firm also indicated that it will undertake a field action (correction) under 21 CFR Part 806 to include customer notification of updated IFUs and labels. However, without evidence of implementation, FDA cannot assess the adequacy of your firm’s response.
2. Failure to establish and maintain procedures to control labeling activities, as required by 21 CFR 820.120.
For example, your firm does not have labeling control procedures for the Surgicraft LockDown Acromioclavicular Device IFUs that are printed in-house and released for use. The product labels are controlled by your firm’s contract manufacturer.
The adequacy of your firm’s response cannot be determined at this time. Your firm indicated that it will establish procedures and work instructions to control the production, checking, storage, release and disposal of labeling and IFUs as well as conduct training. However, without evidence of implementation, FDA cannot assess the adequacy of your firm’s response.
Your firm’s response to this letter 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. 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #438136 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at 301-796-5587 or 301-847-8139 (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.
Steven D. Silverman
Office of Compliance
Center for Devices and
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