Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm355678
Timestamp: 2019-02-23 20:47:30
Document Index: 120700174

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

LISA Laser Products OHG 5/8/13
Dear Dr. Teichmann:
During an inspection of your firm located in Katlenburg-Lindau, Germany, on October 1, 2012, through October 4, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Sphinx Laser Systems, FlexGuard, and Revolix lasers. 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.
We received a response from you dated October 24, 2012, 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:
Our inspection 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 medical device reporting (MDR) procedures, as required by 21 CFR 803.17. For example, during the inspection, your firm stated that it does not have an MDR procedure.
We reviewed your firm’s response and conclude that it is not adequate. Your firm developed a procedure titled “VAMPBeobachtungssystem (Medical Device Reporting), Rev 03V00,” dated October 17, 2012. The procedure fails to meet the requirements of 21 CFR 803.17(a)(1). The following issues were noted:
Procedure VAMPBeobachtungssystem (Medical Device Reporting) does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR. For example:
A. The procedure, as written, combines language from the requirements of other regulatory or competent authorities with the requirements in 21 CFR Part 803 in a manner that will result in incomplete, inadequate, or even non-reporting of adverse events that meet reportability requirements under 21 CFR Part 803. Specifically, under Section 4.2 Definitions according 21 CFR 803 (MDR), the definition of the term “permanent” is not consistent with the definition of the term “permanent” found in 21 CFR 803.3.
B. There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events, and to assure the quality of MDR submissions, your procedure should include definitions based on 21 CFR 803.3 of the terms “become aware,” “caused or contributed,” “five-day report,” “malfunction,” and “remedial action” as well as definitions of the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1).
In addition, your firm’s procedure, VAMPBeobachtungssystem (Medical Device Reporting), Rev 03V00, includes references to baseline reporting, which is no longer required. 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).
Your firm’s CAPA FP2009-005 was not filled out completely. Your firm’s CAPA SOP, VAKorrekturUndVorbeugungsmaßnahmen, task of correction and prevention, effective 6/10/2009, did not require:
Verifying or validating that the CAPA did not adversely affect the finished device;
Ensuring that information related to nonconforming product is disseminated to those directly responsible for assuring the quality of the product or the prevention of problems; and
Submitting relevant information on identified quality problems, as well as CAPAs, for management review.
We reviewed your firm’s response and conclude that it is not adequate. Although your firm provided evidence that a review of the documented CAPA procedure was performed, no documentation was provided. Your firm indicated that a review of all CAPA files would be done by April 2013; however, your firm did not provide evidence or documentation of the completion of that review. Your firm indicated that a review and correction was made to CAPA FP2009-005 and that, by November 2012, a revision of the SOP and training would be accomplished; however, no documentation has been submitted.
2. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e). For example:
Your firm’s design review teams for RevoLix 120W at Phase 1 through Phase 7 did not include one person not involved in the design stages, nor does your firm’s procedure address this requirement.
The adequacy of your firm’s response cannot be determined at this time. Your firm has not reviewed all of its design review files to ensure that all reviews included a person not involved in the design stage process. Although your firm provided evidence that this would be accomplished by December 2012, and indicated that revision of the SOP and forms for the new design review procedure would be completed by November 2012, no documentation has been provided.
3. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example:
Your firm changed its drawing of RigiFib per CAPA FP 2009-004 and distributed these components without conducting validation after the change.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided information in response to the design change to RigiFib by giving details and indicating that it “did not include any material or significant process modification or changes. The change was verified and approved.” However, your firm failed to provide documentation showing the device design change validation for the RigiFib. Additionally, your firm did not indicate or provide documentation that its files were reviewed to ensure that all device design changes have been validated or to show that your firm would be establishing and maintaining adequate procedures for validating device design changes as evidence of a systemic corrective action.
4. Failure to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 CFR 820.50(b). For example:
A. Your firm does not have a quality agreement with (b)(4) in which this supplier agrees to notify your firm of any change.
B. Your firm’s quality agreement with (b)(4) does not contain an agreement in which this supplier agrees to notify your firm of any change.
The adequacy of your firm’s response cannot be determined at this time. Your firm did not provide documentation of a quality agreement with (b)(4). Your firm stated that an agreement would be initiated. Your firm also did not provide documentation showing the additional language that was added to a responsibilities clause with (b)(4). Your firm provided evidence that the following sentences would be added to the agreement: “(b)(4).” Your firm also indicated the agreement was currently under review with the supplier.
Your firm’s Standard Operation Procedure Complaints, VAReklamation06VOOE, effective November 28, 2006, does not require that complaints be evaluated for reportability to FDA.
6. Failure to maintain records of changes to documents to 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:
Your firm’s document control SOP, VADokumentelenkung03V01, effective June 11, 2011, does not require communication of approved changes to the appropriate personnel in a timely manner.
The adequacy of your firm’s response cannot be determined at this time. Your firm did not provide any evidence or documentation to address a correction or corrective action. Your firm indicated that the revision of the SOP would be completed and training given on the new procedure by November and December 2012, respectively. However, your firm has not submitted any documentation.
7. Failure to document service reports that include: (1) The name of the device serviced; (2) Any device identifications and control numbers used; (3) The date of service; (4) The individuals servicing the device; (5) The service performed; and (6) The test and inspection data, as required by 21 CFR 820.200(d). For example:
Your firm’s Service Report No.’s (b)(4) did not include the names of the servicing technicians.
8. Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. These quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. For example:
Your firm did not conduct an internal audit in (b)(4) per the requirement in your firm’s audit procedures.
9. Failure to establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example:
Your firm does not have documents to demonstrate your firm's internal training on Quality Management System. Specifically:
A. Personnel were not made aware of device defects that may occur from the improper performance of their specific jobs.
B. Personnel who perform verification and validation activities were not made aware of defects and errors that may be encountered as part of their job functions.
C. Personnel conducting internal audits did not have formal training on how to conduct an internal audit.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any documentation to address a correction, corrective action, and systemic corrective action. Your firm indicated that all required training would be completed by December of 2012; however, your firm has not submitted any documentation.
Your firm’s response 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 # 394724 when replying. If you have any questions about the contents of this letter, please contact: LaShanda Long, Chief, General Surgery Devices Branch at (301) 796-5465 or fax 301-847-8137.
LISA Laser Product OHG - Close Out Letter 4/1/15