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WARNING LETTER

TALON, an S & S Technology Company MARCS-CMS 580417 —


Delivery Method:
United Parcel Service
Product:
Medical Devices

Recipient:
Recipient Name
Norman A. Shoenfeld, MD
Recipient Title
President & Owner
TALON, an S & S Technology Company

10625 Telge Road
Houston, TX 77095-5023
United States

Issuing Office:
Office of Medical Device and Radiological Health Operations, Division 3

19701 Fairchild
lrvine, CA 92612-2506
United States


WARNING LETTER
CMS # 580417

UNITED PARCEL SERVICE
OVERNIGHT DELIVERY

August 2, 2019

Norman A. Shoenfeld, MD
President & Owner
TALON, an S&S Technology Company
10625 Telge Road
Houston, TX 77095-5023

Dear Dr. Shoenfeld:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm's medical device operations, TALON, an S&S Technology Company, located in Houston, TX, from March 11 - 28, 2019. During the inspection, an FDA investigator determined that your firm is a medical device manufacturer of various Class I & II medical equipment, healthcare supplies, and radiation products used for general and plastic surgery. 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 any function of the body.

This inspection revealed your 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 dated April 24, 2019 from your Quality Assurance Manager which responded to the Form FDA 483, Inspectional Observations issued to your firm on March 28, 2019. We address your response below, in relation to each of the noted observations. These violations include, but are not limited to, the following:

1. Failure to document corrective and preventive action activities and/or results, as required by 21 CFR 820.100(b). During the inspection we observed your corrective and preventive action (CAPA) reports failed to provide documented evidence that corrective actions taken were verified and/or implemented prior to closing the CAPA. For example:

a. CAPA (b)(4) (dtd. 11.21.17) found Internal Audits did not provide evidence audit principles were used. There was no re-audit plan or audit schedule in place to show the effectiveness of the audit planning and performance. The CAPA was closed on 2/23/2018 prior to developing corrective actions.
b. CAPA (b)(4) (dtd. 11.21.17) found that risk analysis is not being conducted. Your proposed corrective actions were to conduct a full review of the risk analysis (for Engineering Project (b)(4)) which included an FMEA, and to train your employees on related procedures such as: Measurement, Analysis and Improvement (SS-001-002); Risk Management Process (SS-004-003); and Risk Management Plan (SS-009-008). No documents were provided to determine that your Engineering Project was completed, risk analysis evaluated, or an FMEA was created prior to closing the CAPA on 2/23/2018.
c. CAPA (b)(4) (dtd. 11.21.17) found employee job descriptions were not created for current job functions. Your proposed corrective action was to update all employee job descriptions. The FDA investigator requested to review job descriptions for your QA Manager, Assembly Supervisor, Quality Technician, Electrical/Mechanical Assembler, and Inventory Supervisor. The CAPA stated all job descriptions were updated reflecting current functions. However, the CAPA was closed on 2/15/18 prior to submitting the new forms and was not verified as closed by your Quality Manager.

We reviewed your firm's response and conclude it is not adequate. Your response indicated that your CAPA system is being re-developed to capture the requirements of 21 CFR 820.100. You referenced the revision of a new procedure, new CAP A form, and new database as part of your re-development to be completed by August 2019. It is unclear if your firm reviewed the observation to determine if both the CAPA examples and retrospective reviews have been conducted for lack of verifying and/or validating CAPA's to ensure that such action is effective and does not adversely affect the finished device. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

2. Failure to establish procedures for design change, as required by 21 CFR 820.30(i). For example:

a. Your firm has not established design change procedures providing instructions for the identification, documentation, validation or where appropriate verification, review and approval of changes before their implementation. Design changes have been approved, implemented, and released before verification could be conducted.
b. There is no documented evidence that design changes to the Class II VAC-FIX System (b)(4) was tested and verified before implementation. The (b)(4) verifies the passing or failing of your (b)(4) equipment final acceptance testing release criteria. In addition, design changes were also identified for the addition of internal padding to the Class II VAC-FIX System shipping box used to minimize damages during transport. Design changes were also made to the (b)(4) of the Class II VAC-FIX System were implemented before the changes could be verified. ECN #'s (b)(4) were reviewed involving these design changes that were not verified prior to implementation.

We reviewed your firm's response and conclude it is not adequate. You indicated your ECN process was not effective in meeting the requirements of 21 CFR 820.30. All design and development procedures are being re-written to capture the requirements of the part to be completed by August 2019. It is unclear if the above mentioned design changes have been reviewed for appropriate verification. Your response does not mention that a design change procedure would be established providing specific instructions to verify and/or validate design changes. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

3. Failure to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). During the inspection we observed your Control of Nonconforming Product procedure (SOP #SS-013) fails to document that the firm will evaluate nonconformances, to include a determination for an investigation. The evaluation and any investigation shall be documented. For example:

a. NCMR #(b)(4) was issued during an in-process assembly of a Class II VAC-FIX System (WO #(b)(4), 02/06/2019). 2 out of (b)(4) components ((b)(4)) did not work and were scrapped. There was no determination made for an investigation and disposition was completed on 3/5/19.
b. NCMR #(b)(4) was issued during an in-process assembly of a Class II V AC-FIX System (WO #(b)(4), 07/19/2018). The (b)(4) component ((b)(4)) was taken from inventory but did not work and was scrapped. There was no determination made for an investigation and disposition was completed on 1/10/19.
c. NCMR #(b)(4) was issued during an in-process assembly of a Class II VAC-FIX System (WO #(b)(4), 12/26/2017). 1 out of (b)(4) units of the (b)(4) component ((b)(4)) did not work and was scrapped. There was no determination made for an investigation. The disposition was completed on 01/10/2019. The NCM form shows that a CAR was required but there was no evidence that it was opened.

We reviewed your firm's response and conclude it is not adequate. Your response indicated your nonconformance system was not as effective in meeting the requirements of 21 CFR 820.90. The nonconformance system is being re-developed to capture the requirements of this part. Your response referenced the revision of a new procedure, new non-conformance fonn, and new database as part of your re-development to be completed by August 2019. It is unclear if the referenced NCMR's and a retrospective review was conducted to determine the need for an investigation and disposition of nonconforming products. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

This is a repeat observation from the previous FDA inspection, dated March 15 - 23, 2011.

4. Failure to adequately maintain device history record, as required by 21 CFR 820.184. For example,

a. You do not maintain batch records for your Class II V AC-FIX System. The QA Manager stated that the firm does not have DHR.s and has not recorded lot/batch numbers for applicable sub-components of the VF-PUMP. Consequently, a serial number is requested for the unit by manufacturing and QA assigns a serial number that is traceable back to a work order. The sales order and date of shipment is tracked into the firm's (b)(4) database.
b. Approximately, (b)(4) Class II V AC-FIX Systems have been manufactured since the previous inspection, without UDI numbers for each marketed and distributed medical devices. There is no documented evidence your firm has controlled the production history of your Class II medical devices.

We reviewed your firm's response and conclude it is not adequate. Your response indicated your DHR requirements is a system failure. As part of the re-write to the design and development process, you plan on addressing the requirements of DHR as per 21 CFR 820.184 for all Class II medical devices. Your response stated a work instruction is being developed to define the process for establishing a Device History File and promised to correct this observation by August 2019. It is unclear what steps have been implemented for addressing the (b)(4) VAC-FIX devices manufactured since the previous inspection without records of production history. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

5. Failure to document acceptance or rejection of incoming product, as required by 21 CFR 820.80(b). During the inspection we observed examples of component parts received that included the "%" prefix to notify your receiving department that Quality Control must be alerted to conduct a visual or dimensional inspection. For example:

a. (b)(4) units of radio cassette bins (Part ID #08-AMI028-1 GY) were received on 2/20/19 that failed to keep technical drawing of the measurements that the parts received met their specification. You did not have specifications for the part and no incoming inspection criteria.
b. (b)(4) units of LEXAN CVR LBC DRWR (Part ID #LBC-28) were received on 6/6/18 that failed to include documented evidence that the measurement of the LBC-28 drawing were within specifications for all units sampled (as per AQL of (b)(4)) by your MRP system.

We reviewed your firm's response and conclude it is not adequate. Your response indicated your receiving, in-process, and finished device acceptance process and applicable procedures needs clarification. As part of the ongoing re-write to the QMS and applicable procedures for receiving inspections are being re-written to capture the requirements of 21 CFR 820.80. Your firm promised to correct this observation by August 2019. We cannot determine if your firm has addressed the examples identified in the observation and if current receiving acceptance activities follows similar deficiencies identified in the Form FDA 483. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

This is a repeat observation from the previous FDA inspection, dated March 15 - 23, 2011.

6. Failure to establish procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements, as required by 21 CFR 820.200(a). For example:

a. Your firm has not established servicing procedures. The inspection revealed that your firm's service records failed to document the use of the Quality Inspection Criteria (QIC) form, for the Class II VAC-Fix System (VF-Pump), to document compliance with internal and final acceptance testing criteria prior to release of repaired devices.
b. Service reports associated with the Class II V AC-FIX System not working, malfunctioned, or caused pump and fuse failures, did not have QIC forms to assure that the device continues to meet current design specification and does not affect the performance of the device. Your firm stated that documentations to assure service repairs met release criteria before they were shipped back to the customer, was not completed. RMA #'s (b)(4) were reviewed involving these servicing issues and there QIC forms.

We reviewed your firm's response and conclude it is not adequate. Your firm's response indicated that servicing activities are being performed but are poorly defined and not effectively implemented. The servicing process is being re-developed to capture the requirements of 21 CFR 820.200. Your response referenced the development of a new procedure, new servicing form, and new database as part of your re-development to be completed by August 2019. We cannot determine if your firm has addressed the examples identified in the observation and if the QIC form is currently being used with the service reports to document compliance with internal and final acceptance testing criteria prior to release of serviced products. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

7. Failure to adequately establish records of acceptable suppliers, contractors, and consultants, as required by 21 CFR 820.50(a)(3). For example:

• Review of your firm's critical component suppliers (for the Class II VAC-FJX System) revealed that they were not evaluated based on your ability to meet specified requirements and specifications and were not monitored based on the type and nature of the product or service you provide. Your firm's critical component (relay, pump, and wiring) suppliers, (b)(4) have been offering product and/or service since 1990. There is no documented evidence that any new or existing suppliers were monitored (b)(4), as per your Purchasing Procedure (SOP #SS-006).

We reviewed your firm's response and conclude it is not adequate. Your firm's response indicated that evaluation of suppliers is being performed but at a reduced rate of effectiveness. Your response states all purchasing controls procedures are bring re-written to capture the requirements of 21 CFR 820.50.

Your response referenced the development of a new procedure, new approved supplier list form, new supplier survey form, and new supplier approval database. The is no indication that your firm promised to correct this observation with a target due date. We cannot determine if your firm has addressed the examples identified in the observation. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

8. Failure to have management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency, as required by 21 CFR 820.20(c). For example:

• During the inspection, Clifton Wall, Quality Assurance Manager stated the most recent management review meeting was held in 2015. However, management review meetings were not conducted in 2011, 2012, 2013, 2014, 2016, 2017, and 2018.

We reviewed your firm's response and conclude it is not adequate. Your response indicated management reviews are being performed but at a reduced rate of effectiveness with poorly defined requirements. The Management Review Meetings procedure (SS-001-001) is being re-written to capture the requirements of 21 CFR 820.20. Your response referenced the development of a new procedure, new management review criteria and results form, and new management review output form. Your firm's response promised to correct this observation by August 2019. We cannot determine if your firm has conducted or plans to conduct management review meetings to determine the suitability and effectiveness of the quality system at defined intervals to ensure that the quality system satisfies the requirements of this part. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

This is a repeat observation from the previous FDA inspection, dated March 15 -23, 2011.

9. Failure to perform quality audits at defined intervals and at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures, as required by 21 CFR 820.22. For example:

a. During the inspection, Clifton Wall, Quality Assurance Manager stated internal audits were only conducted in (b)(4). Since the previous inspection, your firm failed to conduct internal audits in 2011, 2013, 2014, 2015, and 2018. Your firm did not create an internal audit schedule or plan, which references (b)(4) items to be reviewed (b)(4), as required by you Internal Audits procedure (SS-017). The FDA investigator observed discrepancies between the documented procedure and the firm's current auditing practices. The procedure stated an Audit Plan and Schedule is created (b)(4), however there is no evidence that an Audit Plan has been created since 2003.
b. CAPA (b)(4) (dtd. 11121117) found that the result of an ISO Audit did not provide evidence that audit principles were used. There was no audit plan or schedule in place to show the effectiveness of audit planning and performing.

We reviewed your firm's response and conclude it is not adequate. Your firm's response indicated quality audits are being performed but at a reduced rate of effectiveness with poorly defined requirements. The firm's Internal Audit procedure is being re-written to capture the requirements of 21 CFR 820.22. Your response referenced the development of a new procedure, new internal audit schedule, and audit checklist. Your firm promised to correct this observation by August 2019. We cannot determine if the firm has conducted or plans to conduct internal audits to assure that your quality system is in compliance. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

This is a repeat observation from the previous FDA inspection, dated March 15 - 23, 2011.

10. Failure to adequately establish procedures for training and identifying training needs, as required by 21 CFR 820.25(b). For example:

a. The FDA investigator reviewed training records for your Assembly Supervisor, Inventory Supervisor, Quality Technician, and Electrical/Mechanical Assembler for manufacturing your Class Il VAC-FIX System. As per your Training procedure (SS-018), re-fresher training is to be conducted at intervals determined by management to ensure competency. This training will be recorded on form SS-018-002. Review of your employees training records revealed you failed to complete the (b)(4) re-refresher training and did not match current practices associated with the training procedures.
b. Your firm's (b)(4) equipment training procedure, dated 06/11/2016 stated individuals who have been qualified and authorized to perform the (b)(4) test, will have to be re-qualified every (b)(4). There was no documented evidence the Quality Technician, who trains the Electrical/Mechanical Assemblers, had been trained every (b)(4) on conducting (b)(4) testing.

We reviewed your firm's response and conclude it is not adequate. Your firm's response indicated training is being performed but at a reduced rate of effectiveness with poorly defined requirements. Your HR procedure is being re-written to capture the requirements of 21 CFR 820.25. Your response referenced the development of a new procedure, training forms, new hire checklist, and performance review form. Your firm promised to correct this observation by August 2019. We cannot determine if re-trainings were conducted for the individuals qualified and authorized to perform the (b)(4) test. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

This is a repeat observation from the previous FDA inspection, dated March 15 - 23, 2011.

11. Failure to adequately maintain records of changes to documents, as required by 21 CFR 820.40(b).
For example:

a. The table below shows your procedures, the current online revision, and the most current approved (signed) revision of your quality system procedures without matching dates. Your firm indicated that current, date-controlled versions only, are available on-line.

PROCEDURE Document # ON-LINE VERSION

MOST RECENTLY APPROVED VERSION

Control of Quality SS-002 10/15/2015 6/12/2015
Device Master Record SS-004-004 6/21/2016 6/19/2010
Control of Documents SS-005 6/21/2016 8/31/2015
Engineering Change Control SS-005-004 6/21/2016 7/12/2006
Device History Record SS-005-008 06/02/2017 06/21/2016



 

 

 

Additionally, the following Quality System procedures were not adequately maintained as a result of document changes:

b. Control of Document procedure (SS-005), indicated that revision documents will be identified alphanumerically (e.g. ABC1234). However, your firm only documents review and change dates on approved procedures.
c. Training Plan Forms are used instead of Training Assessment Forms, as per firm's Training Procedure (SS-018) requirements.
d. Quality Inspection Criteria (QIC) Form used for VAC-FIX final acceptance test forms, shows a current version online which is not the version used by Production (Assembly).

We reviewed your firm's response and conclude it is not adequate. Your firm's response indicated document controls are being performed but at a reduced rate of effectiveness with poorly defined requirements. The control of documents procedure is being re-written to capture the requirements of 21 CFR 820.40. You referenced the development of several procedures and forms. Your firm promised to correct this observation by August 2019. In response to this Warning Letter, you should provide examples of supporting documentation to determine the adequacy of your corrections.

Medical Device Listing

Further, we also note the FDA investigator observed that you manufacture software-controlled medication cabinets and carts used for security and convenient access to medications and medical supplies, accounting for (b)(4)% of your business. Review of your Talon Med.Key and Med.Key Lite software literatures indicated that the Med.Key Lite software is available on Anesthesia Carts which are Class I Exempt devices, under 21 CFR 868.6100, Product Code BRY. Based on this information, you should register and list this software under the appropriate regulation.

Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means (section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual device listing requirements of the MedKey Lite software for fiscal year 2019.

Additionally, your software literature asserts as part of MedKey Lite benefits that the software has been FDA approved. Upon review of FDA's registration and listings database and premarket notification 510(k) database, we were not able to locate any premarket submissions associated with this product. If the device was exempt from premarket notification, we were not able to locate any information to demonstrate that your firm has listed your MedKey Lite software with the Agency. Therefore, FDA does not agree that the manufacturer can promote FDA approval statements on the firm's website and/or product literatures unless they are able to provide the appropriate application for which approval was received.

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 not 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 (which must address systemic problems) 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 via e-mail to: US Food and Drug Administration, Division 3/West, Office of Medical Device and Radiological Health Operations at ORADevices3FirmResponse@fda.hhs.gov. Please identify your response with CMS case #580417 when replying. If you have any questions about the contents of this letter, please contact Compliance Officer Charles J. Chacko at 214-253-4939, or via email at charles.chacko@fda.hhs.gov,

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 regulation 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,
/S/
Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological Health
Division 3 West

 

Cc: Clifton Wall, Quality Assurance Manager
TALON, an S&S Technology Company
10625 Telge Road
Houston, TX 77905