Linet Spol. S.r.o. 3/1/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
March 1, 2013
VIA UNITED PARCEL SERVICE
Mr. Tomas Kolar
Linet Spol. S.r.o.
Slany, Czech Republic 27401
Dear Mr. Kolar
During an inspection of your firm located in Slany, Czech Republic, on October 29, 2012, through November 01, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures AC powered adjustable hospital beds (Eleganza 3, MultiCare, and Eleganza EZ). 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.
Our inspection revealed that your Eleganza 3, MultiCare, and Eleganza EZ beds 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. We received a response from you dated November 30, 2012, 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. 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. For example, your firm does not have written MDR procedures in place to identify, process, evaluate events and submit the report to FDA.
We reviewed your firm’s response and conclude that it is not adequate. Your firm included a procedure titled “Medical Device Reporting, S15P01I01” dated November 30, 2012. After reviewing your firm’s procedure, we conclude that it fails to establish internal systems that provide for timely and effective identification, communication and evaluation of events that may be subject to the MDR requirements, as required by 21 CFR 803.17(a)(1).
To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” and the definition of the term “reasonably known,” found in 21 CFR 803.50(b).
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov
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 action (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. 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 nonconformances include, but are not limited to, the following:
1. 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’s procedure for complaint handling, “Solving of the Services Cases from USA, S13P01I01, version 1, dated February 11, 2011,” does not contain the following:
a. A requirement to ensure that complaints are processed in a uniform and timely manner.
b. A requirement that, when no investigation is made, a record that includes the reason that no investigation was made and the name of the individual responsible for the decision not to investigate.
c. A requirement that any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specification should be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.
d. A requirement that the record of a complaint investigation shall include the address, phone number of the complainant, and any reply to the complainant.
We reviewed your firm’s response and conclude that it is not adequate. Your firm made revisions to its “Solving of the Service Cases from USA-categories, S13P01I01, version 1,” procedure and its “Change in claim process” form. However, as of the date of the response, your firm has not fully implemented all proposed changes to the “(b)(4).” Your firm has not implemented training relating to the “(b)(4).” Your firm has not implemented modification of connection between the (b)(4) and the (b)(4), for previously-investigated complaints. Also, your firm did not include a plan and evidence of consideration of systemic corrective action, including a retrospective review of other procedures that describes process control, to ensure that conformance to specifications are documented. Your firm did not provide documentation or evidence that it retrospectively reviewed all complaints to ensure that investigations were completed as required or, if investigations were not completed, why no investigation was needed. Also, your firm did not provide documentation or evidence of the current form to ensure that the form includes the complainant’s address and phone number.
2. Failure to maintain records of document changes that include a description of the change, identification of the affected documents, the signature of the approving individuals, the approval date, and when the change becomes effective, as required by 21 CFR 820.40(b). For example, in reviewing your firm’s quality processing records, the following discrepancies were found: errors and changes to documents are not being initialed and dated by the person responsible for the task involved. In addition, white-out solution is used to obliterate information on your firm’s batch records.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a description of its corrective action, including “eliminate the use of white-out or other correction fluid in correction process of quality records” and “create a work instruction for valid correction of quality records in production including training.” Your firm provided a copy of the following: memo “Usage of white out prohibited in Linet” that was sent to all employees on November 19, 2012, and a list of responsible personnel that will be trained to create the Work Instruction “PMV_002_01”, in its response. However, your firm did not provide a revised copy of MultiCare 1MC ((b)(4)), Multicare 1MC ((b)(4)), MultiCare ((b)(4)), and Eleganza 3XC, Eleganza3 ((b)(4)). Also, your firm did not provide a plan and evidence of consideration of a systemic corrective action, including a retrospective review to ensure that other documents are initialed and dated by an approving individual as required.
3. 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’s Design Control written procedure, “Management of Development Projects, S05P07, version 9,” does not include the design input and design output procedures, including requirements that each design review includes an individual who does have direct responsibility for the design stage being reviewed.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a description of the revisions made to the “Management of Development Projects” procedure and evidence that the applicable employees were trained on the revised procedure. Your firm also provided an updated procedure, “Management of Development Projects S05P07, version 11,” that includes the following: a design input procedure, a design output procedure, and a design review procedure dated November 23, 2012, in its response. However, your firm did not include documentation or evidence of consideration of systemic corrective actions that include a retrospective review of design control projects to ensure that your firm adequately conducted design input/output and design review during the design control process.
4. 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 Device Master Record (DMR), as required by 21 CFR 820.184. For example, a review of (b)(4) DHRs for your firm’s AC powered hospital beds (MultiCare, Eleganza 3, and Eleganza Smart) for the period October 2010 through October 2012 found that (b)(4) DHRs (i.e., Eleganza 3 ((b)(4)), MultiCare 1MC ((b)(4)), and MultiCare 1MC ((b)(4))) did not include, or refer to the location of, the following:
a. Acceptance records (i.e., incoming and final) demonstrating that the device was manufactured in according to the DMR, and
b. Your firm’s primary identification label and labeling used for the finished product, lot, or batch to demonstrate that the devices were manufactured according to the DMR.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a revised version of its Controlling Operation in IS-Flow material procedure and provided training to the appropriate personnel. However, your firm did not provide a revised DHR to include your firm’s primary identification label and labeling used for the finished product, lot, or batch to show that the devices were manufactured according to the DMR. Also, your firm did not provide an updated DHR to include dates on when the authorized QC personnel performed a review and final approval to release the device for distribution. Also, your firm did not include documentation or evidence of consideration of systemic corrective actions with the response to FDA, including a retrospective review of all products made to ensure that devices were manufactured according to specifications in accordance with the DMR.
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 Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 392308 when replying. If you have any questions about the contents of this letter, please contact: Carl Fischer, Ph.D., at 301-796-5770 or 301-796-8137.
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 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