Inspections, Compliance, Enforcement, and Criminal Investigations
Sharplight Technologies 11/25/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire A venue|
Silver Spring, MD 20993
November 25, 2013
VIA UNITED PARCEL SERVICE
Shlomi Ben Avi
Chief Executive Officer
Sharplight Technologies Ltd.
33 Lazarov Street
Rishon Le Zion
Dear Mr. Ben Avi:
During an inspection of your firm located in Rishon Le Zion, Israel, on June 10, 2013, through June 13, 2013, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures powered surgical laser instruments. 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.
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 a response from you, dated July 2, 2013, 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 establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). For example: your firm’s design verification procedures, titled, Research and Development, Document no.: SOP 7.3, do not ensure that the design verification results, including identification of the design, methods, and the individuals performing the verification, are adequately documented in the design history file, nor does the procedure ensure that design verification testing is conducted according to established protocols with acceptance criteria prior to initiating the testing. The (b)(4) design verification test records reviewed did not include the required documentation. Additionally, documentation of the test protocol was not available for the verification testing conducted in the report titled, Test Rules Definition & Results (TRDR) Form no.: Omnimax-dhf-trdr-01, Rev. 01, dated 9/17/2009.
Your firm’s response to this observation appears to be adequate. Your firm opened CAPA 06-2013-1 and aligned its design and development procedure with 21 CFR 820.30. Also, your firm submitted documentation showing that the design verification procedure has been updated to include instructions to document design verification results, including identification of the design, methods, and the individuals performing the verification in the design history file. Training records for affected personnel were submitted.
2. Failure to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, your firm's Engineering Change Order (ECO) procedure Document No.: SOP 7.3.2 does not ensure that engineering change requests for changes (including revisions to engineering drawings and component materials) are initiated to control and document all change activities, including prototype development, prototype testing, re-verification, and re-validation testing. The procedure does not require that all such changes are approved prior to implementing the changes. The ECOs reviewed did not include all documentation of the changes and change activities conducted.
The adequacy of your firm’s response cannot be determined at this time. Your firm opened CAPA 06-2013-2 and revised its ECO procedure to ensure that changes were not implemented prior to approval. A retrospective review of (b)(4) ECOs dating back to (b)(4) was conducted and (b)(4) ECOs were identified with missing information. Further analysis of the missing information did not reveal safety issues or that a new 510(k) was required. Your firm stated that these (b)(4) ECOs would have the missing information added by July 25, 2013; please send us copies of the revised ECOs. Training on the revised ECO procedure was conducted.
3. Failure to establish and maintain procedures for validating device design, as required by 21 CFR 820.30(g). For example, the design validation procedures in Research and Development Document no. SOP 7.3 do not ensure that the results of design validation, including identification of the design, methods, the date, and the individuals performing validation, are adequately documented in the design history file. Also, the procedure does not include requirements that ensure that design validation testing is conducted according to established protocols with acceptance criteria prior to the performance of validation activities. For example, Clinical test report Form No.: omnimax-dhf-clinical.test, dated January 5, 2009, does not include identification of the test unit, the individual conducting the test, or the test date. Additionally, the validation test protocol with established acceptance criteria was not available.
The adequacy of your firm’s response cannot be determined at this time. Your firm opened CAPA 06-2013-3 and created a new procedure, 7.3.9 Design Validation. Section 5.3 of the procedure addressed how to document results of design validation, including identification of the design, methods, the date, the individuals performing the validation, and requirements which ensure that the design validation testing is conducted according to established protocols with predefined acceptance criteria before performing validation activities. Training records for the design validation procedure were provided. A (b)(4) of the design validation records for cleared devices was performed and design validation records were to be revised based upon the results of the (b)(4) by July 25, 2013; please send us a copy of the revised design validation records.
4. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate states of the device’s design development, as required by 21 CFR 820.30(e). For example, your firm's design review procedure, Research and Development Document No. SOP 7.3, does not ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and individuals who do not have responsibility for the design stage being reviewed. Additionally, review of the design review meeting records found that not all of the required records were identified as having been reviewed as required by procedure.
The adequacy of your firm’s response cannot be determined at this time. Your firm opened CAPA 06-2013-4 and created a specific SOP for Design Review no. 7.3.7, Rev. 01, and Design Control Documentation Requirements Control List no. F0016, Rev.01. The SOP, under sections 5.5 and 5.6, addresses documenting the participants at each design review. Form F0016 identifies which records are prepared and approved at each design review. Your firm performed a (b)(4) for cleared devices against the new procedure and revision of records as a corrective action which was scheduled to be completed by July 11, 2013. Please send us a copy of your revised records. Documentation of training on the new procedures was provided.
5. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b). For example, copies of the design plans reviewed, updated, and approved during the course of the design project for the Omnimax were not retained in the design history file.
The adequacy of your firm’s response cannot be determined at this time. Your firm opened CAPA 06-2013-5 and retrospectively reviewed design plan records for its cleared devices against revised Design and Development procedure 7.3. Revision of records per the (b)(4) was scheduled to be completed by July 11, 2013. Please send us a copy of the revised records. Documentation of training on the design review procedure was provided.
6. Failure to review, evaluate, and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 198(c). For example, your firm could not provide records to show that Complaint #C012000019 was investigated.
Your firm’s response to this observation appears to be adequate. Your firm opened CAPA 06-2013-6, revised Complaints Handling procedure 9.1.7 to Rev. 7, and complaint form no. CC04.01 to describe how complaints should be handled, investigated, and documented. A (b)(4) of complaint file records was performed and corrective actions were initiated. Documentation of training on the revised procedure was provided.
7. Failure to review and evaluate all complaints to determine whether an investigation is necessary and, when no investigation is made, maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b). For example, your firm did not record the reason an investigation was not required for Complaint #CO12000028.
Your firm’s response to this observation appears to be adequate. Your firm’s corrective action was combined with action taken for CAPA 06-2013-6.
8. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2). For example, your firm's Nonconforming Product Control and Material Review Procedure SOP 8.3, Rev. 06, is not adequately established to ensure that rework of nonconforming product includes retesting and reevaluation of the nonconforming product after rework to ensure that the product meets its current approved specifications. Also, the procedure does not ensure documentation within the device history record of reevaluation activities including a determination of any adverse effect from the rework upon the product. For (b)(4) of the (b)(4) nonconformance records reviewed, retest records were not available for the device after it was reworked.
Your firm’s response to this observation appears to be adequate. Your firm opened CAPA 06-2013-8 and revised its Nonconforming Product Control and Material Review procedure to specifically define the need to re-evaluate and retest reworked product to ensure that it meets currently approved specifications and that re-evaluation/retesting is documented. Training documentation on the revised procedure was provided.
9. 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 and the requirements of 21 CFR 820, as required by 21 CFR 820.184. For example, of the (b)(4) DHRs reviewed, (b)(4) included copies of the labels and labeling used for each finished product. Additionally, (b)(4) of the DHRs reviewed included acceptance test records for the equipment used during some (b)(4) and Omnimax-C dermatologic treatment system in-process and final tests.
Your firm’s response to this observation appears to be adequate. Your firm opened CAPA 06-2013-9 and reviewed and revised the System's Machine Books (ATP) to include information of the test equipment (TE): TE serial number, TE name and calibration validity. In addition, clear instructions to record in the DHR, a copy of the device label, and reference to the user manual were added to the revised ATPs. A retrospective review of (b)(4) devices was conducted and missing labels were affixed to the ATP records. Training documentation on the revised procedure was provided.
10. Failure to establish and maintain procedures for changes to a specification, method, process, or procedure, as required by 21 CFR 820.70(b). For example, a tester was observed using the unapproved work instruction, Work Instruction for Testing Laser (b)(4) (Form No.1, Rev. No. 1), while performing in-process and final tests on a laser (b)(4) used with the Omnimax-C dermatologic treatment system.
Your firm’s response to this observation appears to be adequate. Your firm opened CAPA 06-2013-10, performed a retrospective review of work instructions for its cleared devices, and approved (b)(4) work instructions that were missing approval signatures. Training documentation on Documentation Control procedure 4.2.3 was provided.
11. Failure to establish and maintain procedures to control all documents as required by 21 CFR 820.40. For example:
a. The date of issue was not included on all documents, including Document Control procedure SOP 4.2.3.
b. There were multiple versions of Complaint form CC04.01, Rev. 1, that did not go through the approval process.
c. Complaint and CAPA logs are not controlled although they contain information derived from firm procedures.
d. Design History File, Chapter 9, Rev. 04 (23 Nov 2011), was not marked per procedural requirements for obsolete documents.
In addition, at least (b)(4) quality records were found to be either incomplete, without signature or date, or contained an incorrect sign-off date.
The adequacy of your firm’s response cannot be determined at this time. Your firm opened CAPA 06-2013-11 and reviewed and revised the Documentation Control procedure SOP 4.2.3, Rev. 06, to align with CFR 21 820.40 and define how controlled documents will be modified and approved. Training documentation on the revised Documentation Control procedure was provided. Your firm will review its quality procedures and related forms as well as records such as complaints, CAPA, CAPA log, ECO, and ECO log to verify compliance with the revised documentation control procedure. Full implementation of this corrective action will be completed by December 12, 2013.
In addition, FDA has noted nonconformances with regards to the Electronic Product Radiation Control provisions of the Food, Drug and Cosmetic Act, found at 21 CFR 1040. These nonconformities include, but are not limited to, the following:
1. Failure to permanently affix or inscribe a certification label or tag, as required by 21 CFR 1010.2. For example, your firm could not provide evidence to show that a certification label or tag is affixed or inscribed on the Omnimax-C platform dermatologic treatment system with laser technology nor was a certification label observed to be affixed or inscribed on the device.
Your firm’s response to this observation appears to be adequate. Your firm opened CAPA 06-2013-12, revised and approved the instruction defining where the label shall be affixed and its location in the System’s Machine books (ATP), and provided a copy of the revised and approved Label # (b)(4), Rev. 1.4. The OmniMax Machine Book (ATP) ((b)(4), rev. 22, page 3) was revised to affix the certification label after laser tests are performed and personnel were trained accordingly. Documentation of training records was provided.
U.S. 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 deviations are reasonably related will not be approved until the violations 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, 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.
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 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 411909 when replying. If you have any questions about the contents of this letter, please contact: LaShanda Long,Branch Chief at (301) 796-5770 or by fax: (301) 847-8147.
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
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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