Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm401616
Timestamp: 2019-02-24 00:47:49
Document Index: 210743932

Matched Legal Cases: ['§ 321', '§ 351', 'art 820', 'art 803', 'art 803', 'art 803', '§ 352', '§ 360', 'art 806']

MTI Precision Products LLC. 6/6/14
Mr. Haye Hinrichs
MTI Precision Products LLC (Business name is MTI Dental Products)
730 Airport Road, Suite 1
14-NWJ-08
Dear Mr. Hinrichs:
During an inspection of your firm located at 730 Airport Road, Lakewood, New Jersey from April 17, 2014 through April 30, 2014, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Lynx TM20 TorqueMaster low speed dental handpiece, Lynx high speed handpiece, Lynx classic motor low speed with nose cone attachments, and Ultasonic-Lynx-SM Sonic Scaler. 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 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received your response, dated May 16, 2014, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. 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 implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm has failed to implement corrective and preventive action which would include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has implemented written procedures for corrective and preventive action.
2. Failure to establish and maintain adequate 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). Specifically, Design Controls procedure, dated January 5, 2009, references SOP AD-006 (2009) for the identification, documentation, validation, verification, review and approval of design changes before their implementation is in place. However, SOP AD-006 (2009) does not require validation or where appropriate verification of design changes before their implementation.
a. The assembly procedure for the Scaler device contains a drawing for the 4-hole Scaler connector body (drawing # (b)(4)) that documents revisions occurred on 6/2/06 and 7/7/06 that involved the (b)(4) and (b)(4) respectively.
b. The assembly procedure for the Scaler device contains a drawing for the (b)(4) (drawing # (b)(4)) that documents dimensional changes were made on 8/20/07 and 12/4/07.
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has established written procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.
3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure complaints are evaluated in order to determine whether the complaint represents an event which is required to be reported to FDA under part 803, Medical Device Reporting, as required by 21 CFR 820.198(a)(3). Specifically, Your Complaint Handling procedure (AD-007) does not ensure that all complaints are evaluated to determine if the complaint contains an MDR reportable event.
a. Notepad Entry for customer (b)(4) states on January 15, 2013, that your high speed handpiece (PB21111003) device was in pieces in the patient’s mouth (turbine was in pieces). This event was also documented as a Complaint (HH007-13, dated January 28, 2013) where your firm stated that no injury was confirmed. However, no evaluation of MDR Reportability was performed by your firm in order to determine if this event was a malfunction and would be likely to cause or contribute to a death or serious injury if the malfunction should recur.
b. On May 7, 2012, your firm received a complaint from customer (b)(4) concerning a sharp edge on the nose portion of the TM20, a low speed dental handpiece. Your firm investigated the complaint and determined the TM20 housing edge feels “edgier” than previous batches of product. Your firm failed to evaluate this complaint in order to determine whether the complaint represents an event which is required to be reported to FDA under part 803, Medical Device Reporting.
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has established written procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803, Medical Device Reporting.
4. 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). Specifically, Complaint Handling procedure (SOP AD-007), states all complaints defined as written or oral expression of dissatisfaction relative to the identity, quality, reliability, safety, effectiveness, or performance of any products manufactured by MTI Precision Products will be subject to management review and/or investigation and will result in prompt response and corrective action where indicated. However, not all complaints, such as customer complaints handled as service repairs, are reviewed and evaluated by your management (members of the designated complaint team).
a. Invoice (b)(4) from (b)(4) documents two nose cones being returned for possible manufacturing defect since they were not working. Your firm chose to treat this issue as a repair rather than reviewing and evaluating this communication from your customer as a complaint.
b. On April 7, 2014, your firm received a call from customer (b)(4) concerning your Micromotor Lynx TM20 which was received from your firm without a serial number. On April 14, 2014, your firm marketed this handpiece with serial # T41308799 without reviewing and evaluating this communication from your customer as a complaint (no investigation was initiated by your firm to determine why your device was shipped without a serial number).
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has established written procedures for receiving, reviewing, and evaluating complaints by a formally designated unit.
5. 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. Specifically, procedure MH-008 (Purchasing Materials and Components), issued November 12, 2012 states “(b)(4).” Procedure AD-021 (Component Master Documentation), issued November 12, 2012 also states “(b)(4)”. Your firm has failed to evaluate, document, and select potential suppliers on the basis of their ability to meet specified requirements, including quality requirements.
For example, your firm initiated a recall of TM 20 low speed dental handpieces as a result of a complaint received from your customer on May 7, 2012. The complaint indicates a recall was initiated because of a sharp edge on the nose portion of the TM20 bodies (TM20 housing part # (b)(4)) which was supplied to your firm from (b)(4). A Corrective Action Analysis Report submitted by your supplier ((b)(4)) states that the (b)(4) used to manufacture the TM20 housing (part number (b)(4)) did not include an operation for machining an (b)(4). Your supplier’s corrective action was to update the (b)(4) by adding a process for machining an (b)(4) at the (b)(4) diameters after the product nonconformity was discovered by your customer. Your firm has failed to evaluate, document, and select a supplier for the TM20 housing on the basis of their ability to meet specified requirements, including quality requirements, which has resulted in a product recall of your TM 20 low speed dental handpieces from commercial distribution.
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has established written procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
6. Failure to establish and maintain procedures to control product that does not conform to specified requirements which addresses the evaluation of a nonconformance to include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance, as required by 21 CFR 820.90(a). Specifically, your procedures (MTI Quarantine Procedure 2013/14, MTI Dental Products Product Conformance Testing Protocol, effective date February 19, 2012, and Procedure: Part Quality Problems in Assembly, dated November 15, 2013) fail to address the evaluation and documentation of a nonconformance to include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has established written procedures to control product that does not conform to specified requirements.
7. 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). Specifically, your firm initiated a recall of your TM 20 low speed dental handpieces as a result of a complaint received on May 7, 2012 concerning a sharp edge on the body of the TM 20. Your corrective action was to rework all existing stock using a (b)(4). Your firm has failed to document these rework activities, including a determination of any adverse effect from the rework upon the product.
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has established written procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications.
8. Failure to maintain device history records that include, or refer to the location of, the following information: The dates of manufacture; The quantity manufactured; The quantity released for distribution; The acceptance records which demonstrate the device is manufactured in accordance with the Device Master Record; The primary identification label and labeling used for each production unit; and any device identification(s) and control number(s) used, as required by 21 CFR 820.184. Specifically, your firm has failed to maintain device history records and has failed to implement your quality manual procedure for “Device History Record”, issued November 5, 2009, which documents the requirements for what is to be included, or refer to the location of, in a device history record.
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has begun to maintain device history records, as required by 21 CFR 820.184.
9. Failure to conduct quality 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, as required by 21 CFR 820.22. Specifically, your firm has failed to implement your quality manual procedure for “Quality Audit”, issued November 15, 2013, which documents quality audits need to be conducted and documented.
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has begun conducting and documenting quality audits.
10. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). Specifically, your firm has failed to implement procedure AD-004, “Good manufacturing (GMP) Training”, issued November 12, 2012 by not documenting the training received by your employee’s in their training record.
We reviewed your firm’s response and conclude that it is not adequate because no evidence was provided to demonstrate your firm has begun to document personnel training.
Our inspection also revealed that your firm’s Lynx TM20 TorqueMaster (K940261) low speed dental handpiece 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 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
Failure to submit a written report to FDA of any correction or removal of a device initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health, as required by 21 CFR 806.10(a).
For example: Your firm initiated a recall on or about May 9, 2012 of all TM 20 low speed dental handpiecies manufactured between March 1, 2012 and May 7, 2012 (voluntary recall letters were sent to your customers requesting them to return TM20 handpieces in order to evaluate and refurbish or replace) as a result of a complaint received from your customer on May 7, 2012. The complaint indicates a recall was initiated because of a sharp edge on the nose portion of the TM20 bodies (TM20 housing part # (b)(4)) which was supplied to your firm from (b)(4). A Corrective Action Analysis Report submitted by your supplier ((b)(4)) states that the (b)(4) used to manufacture the TM20 housing (part number (b)(4)) did not include an operation for machining an (b)(4). Your supplier’s corrective action was to update the (b)(4) by adding a process for machining an (b)(4). In addition, your firm changed incoming inspection of the TM20 bodies to include checking (b)(4). Furthermore, your firm reworked all returns and existing stock using a (b)(4).
You 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Your response should be sent to: Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter, please contact Mr. Maffei at 973-331-4906.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.