Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lockdown-medical-ltd-09112014
Timestamp: 2020-07-03 18:02:14
Document Index: 326647111

Matched Legal Cases: ['§ 321', '§ 352', '§ 360', 'art 803', 'art 803', 'art 806']

LockDown Medical Ltd. - 09/11/2014 | FDA
LockDown Medical Ltd. - 09/11/2014
LockDown Medical Ltd. September 11, 2014
LockDown Medical Ltd.
Mr. Andrew T. Hull
16 The Oaks, Clews Road
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:
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:
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;
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).
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).