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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lucero Medical, LLC 3/21/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761 

March 21, 2012

WARNING LETTER CIN-12-269897-13

VIA UNITED PARCEL SERVICE

Michael V. Conrad
President
Lucero Medical, LLC
400 Wakefield Run Boulevard
Hinckley, Ohio 44233

Dear Mr. Conrad:

During an inspection of your firm located in Hinckley, Ohio, on November 15, 2011, through November 22, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the specification developer and distributor of Enduramesh, an implantable spinal vertebral replacement device. 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 are intended to affect the structure or any 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 your response dated December 1, 2011, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of inspectional Observations, that 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 establish and maintain procedures to control the design of a device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).

For example, your firm does not have any design control procedures, did not exert formal design controls during initial design of the Enduramesh device, and has not exerted design change controls for the Enduramesh device.

We reviewed your firm's response and conclude that it is not adequate. The response promises that a fully-implemented design control procedure will be in place by March 28, 2012, but Lucero has not provided a new design control procedure or evidence of its implementation. In addition, your firm has not provided any retrospective review of the Enduramesh design or any changes to the Enduramesh design to determine if additional design control activities are necessary.

2. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a).

For example, your firm does not have any procedures for implementing corrective and preventive actions.

We reviewed your firm's response and conclude that it is not adequate. The response promises that a fully-implemented CAPA procedure would be in place by February 29, 2012, but Lucero has not provided a new CAPA procedure or evidence of its implementation. In addition, your firm has not provided an evaluation of previous possible CAPA inputs to determine if there are any instances where a CAP A should have been initiated.

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).

For example, your firm does not have any procedures for complaint handling.

We reviewed your firm's response and conclude that it is not adequate. The response promises that a fully-implemented complaint handling procedure would be in place by February 29, 2012, but Lucero has not provided a new complaint handling procedure or evidence of its 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.

For example, your firm does not have any procedures for purchasing controls and does not exert any purchasing controls on the supplier of the Enduramesh, (b)(4).

We reviewed your firm's response and conclude that it is not adequate. The response promises that a fully-implemented supplier controls procedure would be in place by February 29, 2012, but Lucero has not provided a new supplier controls procedure or evidence of its implementation. In addition, your firm has not provided evidence that it has performed purchasing control activities regarding the supplier, (b)(4), or any evaluation to determine whether product previously received from (b)(4) conforms to specified quality requirements.

5. Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a).

For example, your firm does not have any procedures for receiving acceptance activities or final acceptance activities.

We reviewed your firm's response and conclude that it is not adequate. The response promises that a fully-implemented acceptance activities procedure would be in place by February 29, 2012, but Lucero has not provided a new acceptance activities procedure or evidence of its implementation. In addition, your firm has not provided protocols outlining the methods and acceptance criteria used for receiving and final acceptance activities for the Enduramesh device, or evaluation to determine whether previously-manufactured Enduramesh devices conformed to defined acceptance criteria.

6. Failure to maintain adequate device master records (DMR) and to ensure that each DMR is prepared and approved in accordance with 21 CFR Part 820.40, as required by 21 CFR 820.181.

For example, the DMR for the Enduramesh spinal verterbral body replacement device does not include the following:

a. All production process specifications, including operations conducted by several contract manufacturers;
b. Quality assurance procedures and all current device specifications; and
c. All packaging and labeling specifications.

We reviewed your firm's response and conclude that it is not adequate. The response promises that a fully-implemented DMR will be in place by March 30, 2012, but Lucero has not provided information outlining what will be included in the DMR, evidence of the development of a DMR, or evidence that activities are being performed in accordance with the DMR. In addition, your firm has not collected any retrospective information to determine if previously-manufactured devices were produced using appropriate methods and specifications.

7. Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR Part 820, as required by 21 CFR 820.184.

For example, your firm does not have any procedures for maintaining DHRs and has not maintained DHRs.

We reviewed your firm's response and conclude that it is not adequate. The response promises that a fully-implemented DHR procedure will be in place by March 28, 2012, but Lucero has not provided a new DHR procedure or evidence of its implementation. In addition, your firm has not provided any evidence of collection of retrospective information to determine whether previously manufactured devices conformed to specified requirements and 21 CFR Part 820.

8. Failure to establish a policy and objectives for, and commitment to, quality by management with executive responsibility, as required by 21 CFR 820.20(a).

For example, your firm does not have a quality policy or objectives.

We reviewed your firm's response and conclude that it is not adequate. The response promises that fully-implemented quality system procedures will be in place by March 23, 2012, but Lucero has not provided any quality system procedures or evidence of their implementation. In addition, your firm has not provided any retrospective review of previously-manufactured devices to determine if they conform to defined quality requirements.

Our inspection also revealed that your firm's 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. Significant violations include, but are not limited to, the following:

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.

We reviewed your firm's response and conclude that it is not adequate. The response promises that a fully-implemented MDR procedure would be in place by February 29, 2012, but Lucero has not provided a new MDR procedure or evidence of its implementation.

Our inspection also revealed that the Enduramesh device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) 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). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Specifically, the Enduramesh device with a (b)(4) (b)(4) differs from the device that was cleared under 510(k) K093207 (b)(4), (b)(4) of the device. The (b)(4) would make the marketed device a new worst-case construct. Also, the (b)(4) is a concern because, in response to Deficiency # 1 of the letter requesting additional information dated December 31, 2009, your firm states that the (b)(4) was a cause for the (b)(4) that was seen on a previous version of the subject device. For this reason, your firm changed (b)(4) of the subject device to (b)(4). These two changes constitute changes or modifications in the device that could significantly affect the safety or effectiveness of the device and therefore require a new 510(k), as required by 21 CFR 807.81(a)(3)(i).

In addition, though the outer package label indicates that the device is for single-use only, you indicated during the inspection that you have instructed surgeons to (b)(4) implantable Enduramesh devices that the surgeon tried to (b)(4). The surgeons were then instructed to (b)(4). A change from a single-use only device to a (b)(4) device constitutes a major change or modification in the intended use of the device and therefore requires a new 510(k), as required by 21 CFR 807.81(a)(3)(ii).

A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.

Your firm should take prompt action to correct the 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. Also, 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 violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will riot be granted until the violations related to the subject devices 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, 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 (including any systemic corrective actions) 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.

Your firm's response should be sent to: Cincinnati District Office. Refer to the Unique Identification Number #CIN-12-269897-13 when replying. If you have any questions about the contents of this letter, please contact: Stephen J. Rabe at 513-679-2700 ext 2163.

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 yours,

/s/

Paul J. Teitell
District Director
Cincinnati District