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  5. US Infusion, Inc. dba Truecare Biomedix-USA - Company - 444968 - 12/17/2014
  1. Compliance Actions and Activities

RESPONSE LETTER

US Infusion, Inc. dba Truecare Biomedix-USA - Company


Company:
US Infusion, Inc. dba Truecare Biomedix-USA - Company

Truecare

December 17, 2014

U.S. Food and Drug Administration
c/o Randall L. Morris, Compliance Officer
555 Winderley Place, Suite 200
Maitland, FL 32751

Re: Warning Letter FLA-15-08 to US Infusion, Inc. dba Truecare Biomedix-USA

Dear Mr. Morris:

This letter provides the US Infusion, Inc. dba Truecare Biomedix-USA (herein after referred to as Truecare Biomedix) response to the Food and Drug Administration's (FDA) Warning Letter dated November 24, 2014 and received on November 26, 2014 (Attachment 1) related to the inspection of the Truecare Biomedix facility on September 11-17, 2014. As the Warning Letter notes, Truecare Biomedix responded to FDA's observations on October 6, 2014. In an effort to more completely respond, Truecare Biomedix sent a detailed update on October 30, 2014 in order to address FDA's concerns more thoroughly. Truecare Biomedix has since been apprised of the FDA's policy regarding only accepting information that is submitted within the 15 day allowance for a FDA Form 483 response. The enclosed response provides details to address FDA's concerns for each ofthe eleven items defined within Warning Letter FLA-15-08.

In addition to our detailed responses within this packet to those areas of concern, we wish to make two general points in this response. First, as FDA has recognized, the issues identified with the Warning Letter and FDA Form 483 response are commonly related to the need for training regarding FDA regulations and guidelines. It is clear to Truecare Biomedix management that a broad focus related to QSR training, as well as resolution of all issues, is required. Truecare Biomedix is dedicated to ongoing training and effective monitoring of SOP implementation, and will focus on the following key areas:

21 CFR, Part 820
Good Documentation Practices

Second, we are prepared to take all necessary steps to respond to the areas of concern identified by FDA. Truecare Biomedix is committed to working openly and cooperatively to address the Agency's concerns in a timely fashion, and is further committed to ensure that any actions taken to address the FDA's concerns are comprehensive and complete. To that end, Truecare Biomedix will provide monthly updates to FDA regarding any actions that are not complete at the time of this response submission.

To confirm our commitment, we would like to request a review of our response and invite your feedback as to its adequacy. In order to improve communications with FDA and to ensure TrueCare Biomedix compliance activities fully meet FDA requirements, we request a meeting with FDA as soon as practical to review the stated corrective actions to address the FDA's concerns are comprehensive and complete. To that end, Truecare Biomedix will provide timely updates to FDA regarding any actions that are not complete at the time of this response submission.

To confirm our commitment, we would like to request a review of our response and invite your feedback as to its adequacy. In order to improve communications with FDA and to ensure TrueCare Biomedix compliance activities fully meet FDA requirements, we request a meeting with FDA as soon as practical to review the stated corrective actions.
If you have any questions, please feel free to contact me directly at the office at 305-593-8444, ext. 205 or email at mparness@tcbiomedix.com.


Sincerely,

/S/

Marc I. Parness, President
True Care Biomedix-USA
www.tcbiomedix.com


CC:
Elizabeth W. Ormand, Acting Director, Florida District, FDA (Desk copy, letter only)


Attachments:
 

1. Food and Drug Administration's (FDA) letter dated November 24, 2014
2. CAPA CAR 14-001-A
3. SOP-001, Supplier Evaluation and Monitoring
4. SOP-002, Purchasing
5. QF-001, Approved Supplier List
6. QF-016, Supplier Audit Checklist
7. CAPA CAR 14-001-B
8. Memo from (b)(4)
9. CAPA CAR 14-001-C
10. Image www.tcbiomedix.com, Updated Website "About" Page as of October 30,2014
11. QF-007-2, Audit Report# 121514-001 re: Website Review, completed December 15, 2014
12. QF-016, Supplier Audit Checklist for (b)(4) with associated summary report dated December 10, 2014.
13. QF-016, Supplier Audit Checklist for (b)(4)
14. CAPA CAR 14-003
15. SOP-007, Internal Audits with associated forms QF-007-1, Internal Audit Plan and QF-007-2, Audit Report form
16. CAPA CAR 14-005-A & B
17. SOP-008, Corrective and Preventive Actions
18. QF-008, Corrective and Preventive Actions Request form
19. CAPA Tracking Log
20. QF-022, Personnel Training Form re: CAP A basic training performed December 11, 2014
21. CAPA CAR 14-004-A
22. SOP-009, Control ofNon-conforming Products
23. QF-009-2, Disposal/Destruction of Product dated October 28, 2014
24. Return Material Reconciliation Form completed for Item# MS721, Lot# 20111115
25. List of SOP number changes
26. CAPA CAR14-004-B
27. CAPA CAR 14-006
28. SOP-003, Design Control
29. Risk Assessment, English Version
30. SOP-020, Process Risk Analysis
31. CAPA CAR 14-007
32. SOP-004, Change Control for Finished Products and Processes
33. QF-014, Engineering Change Record
34. CAPA CAR 14-008-A
35. SOP-012, Customer Complaints
36. SOP-018, Medical Device Reporting (MDR)
37. QF-018-1, FDA Reportable Complaints
38. Master Complaint and MDR Tracking Log
39. SOP-019, Quality Investigations
40. QF-012-1, Complaint Investigation Form
41. CAPA CAR 14-008-B
42. MedWatch, Form FDA 3500A completed for three (3) events, June 2012- July 2012, submitted December 10, 2014
43. CAPA CAR 14-010
44. SOP-005, Control of Documents
45. (b)(4) Recall Enforcement Report, dated August 15, 2012 and the MSD letter dated December 16, 2014 regarding the termination of the recall on January 14, 2013
46. TCB recall communication dated December 16, 2014
47. SOP-011, Device Recall and Advisory Notices
48. Health Hazard Evaluation (HHE) worksheet
49. Return Material Reconciliation Form
50. CAPA CAR 14-002 and CAPA CAR 14-011
51. CAPA CAR 14-009
52. Truecare Biomedix Purchase Order
53. (b)(4) Acceptable Quality Limits (AQL)
54. Complaint Investigation forms completed December 15, 2014 for three (3) events, June 2012 - July 2012 

- End of Attachments List -

The following are detailed responses to the issues noted in the Warning Letter. Those issues are restated below in bold, followed by the Truecare Biomedix response.

WL 1

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,
 

a) Your firm's Purchasing Control procedures (both in Quality Manual and in SOP-011 (not dated) do not adequately describe methods by which the firm assures its potential contractors/suppliers will provide products according to its specifications consistently in that it does not assure verification that suppliers/contractors have adequate Quality Control program including but not limited to personnel qualification for bonding, process validation of special and automated processes such as extrusion, and maintenance of equipment. Firm has acquired documentation from its present IV administration set contractor including (b)(4) sterilization validation, package integrity validation, and Certificates of Analysis and Sterilization, but these documents are not required to be obtained in the firm's Purchasing Control procedures for any potential future suppliers/contractors.

True care acknowledges that their Purchasing Controls did not require documentation of (b)(4) Sterilization validation, package integrity validation, Certificates of Analysis and Sterilization for every batch with proof of use of Biological Indicators during routine sterilization. To ensure that the products imported by Truecare Biomedix met requirements the following actions were taken:
 

 

 WL#  Action  Status
 
 1a CAPA plan CAR 14-001-A was established to plan corrective and In-process, see preventive actions. CAR will be in-process until the effectiveness is verified. In-process, see Attachment 2
 1a SOP-001, Supplier Evaluation and Monitoring, updated to include verification of personnel training for bonding; process validation for processes including extrusion, (b)(4) Sterilization, and package integrity; Certificates of Analysis; and use of Biological Indicators during sterilization for all new vendors. Complete, see Attachment 3.
 1a SOP-002, Purchasing, updated to include an approved supplier list which is based upon the requirements in SOP-001 and require supplier audits. Complete, see Attachment 4 
 1a Generate an Approved Supplier List, QF-001  Complete, see Attachment 5
 1a Generate a Supplier Audit Checklist  Complete, see Attachment 6
 1a Provide Acceptable Quality Limits document for reference from main supplier, (b)(4) Complete, see Attachment 53 


b) Your firm receives Certificate of Sterilization from its current IV administration set contractor which states in part that the product was "sterilized by (b)(4) and without microorganism" (sic). The firm's President stated US Infusion personnel do not know if this means the contractor does not use biological indicators during routine sterilization and if so whether this method is adequately controlled.

Truecare Biomedix acknowledges that it did not thoroughly understand the frequency behind the wording, "sterilized by (b)(4) and without microorganism". In order to more clearly ascertain the meaning, the supplier that used the wording, (b)(4) Ltd. was contacted by Truecare Biomedix to confirm BI use with each run amongst other agenda items.
 

 

WL#  Action  Status 
1b  CAPA plan CAR 14-001-B was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified. In-process, see Attachment 7 
1b SOP-001, Supplier Evaluation and Monitoring, updated to include validation for (b)(4) Sterilization and use of Biological Indicators during sterilization for all new vendors. Complete, see Attachment 3
1b  Truecare Biomedix obtained a letter from (b)(4) limited to clarify wording and obtained a sample BI Test Result Report as an example of the type of report that will be sent with each lot. Complete, see Attachment 8 
1b  Truecare Biomedix will obtain a report for BIs used with each Pending sterilization run for product batches supplied to Truecare Biomedix from the approved supplier, (b)(4). BI certification will be sent with the next shipment which is anticipated to arrive before March 1, 2015 Pending 

c) It is stated on your firm's website that all suppliers are audited quarterly, however the firm's President stated that all suppliers are not audited quarterly.

Truecare understands that the website was in error. The following steps were taken to remedy the situation.
 

 

WL#  Action  Status 
1c  CAPA plan CAR 14-001-C was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified. In-process, see Attachment 9 
1c  SOP-001, Supplier Evaluation and Monitoring, updated to clarify supplier audit frequency with suppliers of IV products required to be audited each year. Complete, see Attachment 3 
1c  The incorrect wording was removed from the website page on September 26, 2014 and documented on December 15, 2014.  Complete, see Attachment 10 
1c  An internal review of the website was performed on September 26, 2014 and documented on December 15,2014 to verify the accuracy of the information displayed on each page of the website. Complete, see Attachment 11 

The adequacy of your firms response dated October 6, 2014 cannot be determined at this time. Your response includes newly established procedures that describe the mechanisms that your firm will use to assure quality control. We disagree with your assertion that your firm always required these procedures as they were not available to our investigator during the course of the inspection. Additionally, you state in your response that your firm now has policies requiring documentation of personnel training and qualification for bonding, (b)(4) sterilization validation, package integrity validation, and Certificates of Analysis and Sterilization from its suppliers as well as other information, however you failed to provide supporting documentation with your written response. Additionally, to date you have not provided documentation that you have conducted audits as required by your newly revised SOPs and website.

 

WL#  Action  Status 
Additional  As noted, Truecare Biomedix has instituted new procedures to require their vendors have documentation of personnel training and qualification for bonding, (b)(4) sterilization validation, package integrity validation, and Certificates of Analysis and Sterilization from its suppliers. Please see SOP-001, Supplier Evaluation and Monitoring. Complete, see Attachment 3 
Additional  Truecare Biomedix performed a vendor audit of (b)(4) on October 10-11, 2014 prior to development of the Supplier Audit Checklist and combined supplemental vendor evaluation information in accordance with the Supplier Audit Checklist, Rev A on December 5, 2014. Complete, see Attachment 12 
Additional  Truecare Biomedix performed a vendor audit of (b)(4) Limited on October 12-13, 2014 prior to development of the Supplier Audit Checklist and combined supplemental vendor evaluation information in accordance with the Supplier Audit Checklist, Rev A on December 9, 2014. Complete, see Attachment 13 
Additional  The audit findings will be reviewed in the next management Pending meeting scheduled on or before February 28, 2015 Pending 

WL 2

Failure to establish 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 as required by 21 CFR 820.22. For example:

It is stated in your firm's Internal Audit SOP-001 dated 11/15/2012 that it is required to generate an audit schedule and that the schedule is such that all major systems and areas are covered at least once a year. The firm has no documented schedule, no documented specific internal audit criteria, and has not completed any official internal audits.

We cannot determine the adequacy of your response, dated October 6, 2014, at this time and can only determine the effectiveness of your quality system through a follow up inspection. The effectiveness of your quality system will be verified during our next scheduled ·inspection. We acknowledge your commitment to conduct an internal audit in January of 2015 and submission of revised procedures.


The following actions pertain to this observation:
 

 

WL#  Action  Status 
CAPA plan CAR 14-003 was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified. In-process, see Attachment 14 
Internal Quality Audits SOP-007 was generated along with Internal Audit Plan, QF-007-1 and an Audit Report form, QF-007-2. Complete, see Attachment 15 
The internal audit scheduled for November 10, 2014 was postponed to all for use of a third party auditor. The audit is scheduled to take place on or before January 31, 2015. Pending 

WL 3

Failure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100 (a). For example:

Your firm's Corrective Action procedures (Corrective Action System SOP-019 dated 11/15/2012 and Problem Reporting SOP-002 dated 11/15/2012) do not include:

a) Requirements to verify or validate corrective/preventative action as effective and they will not adversely affect the finished device.
b) Definitions of preventative actions or how preventive actions will be controlled.

We acknowledge receipt of your revised Corrective and Preventive Action SOP-008, however it is inadequate in that it fails to include key requirements identified under 21 CFR 820.100(a)(1). For example:

Your revised procedure does not include a requirement that appropriate statistical methodology shall be employed where necessary to detect recurring quality problems as required by 21 CPR 820.100(a)(1).


Truecare Biomedix understands that the SOP submitted was found deficient, including proper CAPA trending and evaluation methods, and has taken the following actions:
 

 

WL#  Action  Status 
CAPA plan CAR 14-005-A&B was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified.
 
In-process, see Attachment 16 
Corrective Action System SOP-019 dated November 15, 2012 and Problem Reporting SOP-002 dated November 15, 2012 were replaced by SOP-008, Corrective and Preventive Action. Most recently updated Rev B provides for effectiveness verification as well as appropriate statistical methodology for CAPA evaluation within quality data analysis. Complete, see Attachment 17 
Establish QF-008, Corrective/Preventive Action Request form  Complete, see Attachment 18 
Generate the CAPA tracking log   Complete, see Attachment 19 
Additional training on CAPA was provided for QA on December 11, 2014. Complete, see Attachment 20 

WL 4

Corrective and preventive action activities and/or results have not been adequately documented, as required by 21 CFR 820.100(b).

Specifically, your Corrective/Preventive Action Request #3, dated 7/8/2012, initiated because of firm's receipt of three complaints related to leaking of its IV administration sets which had potential to harm patients was inadequate in that:

 

a) Although it stated all defective sets were to be returned under RMA (Returned Materials Authorization), there is no documentation verifying this action included destruction of the defective products.
 

Truecare acknowledges that the disposition of the inventory was not adequately documented at the time of the incident. In order to correct and prevent this issue from occurring again, the following steps were taken:
 

 

WL#  Action  Status 
4a  CAPA plan CAR 14-004-A was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified. In-process, see Attachment 21 
4a  SOP-009, Control of Non-conforming Products, was generated.  Complete, see Attachment 22 
4a  Quality Form, QF-009-2 detailing this specific incident was completed Complete, see Attachment 23 
4a  A Return Material Reconciliation form was generated with disposal letters and completed for this incident though significantly after the fact. Complete, see Attachment 24 

b) Although it stated the subject contractor, (b)(4) (which was responsible for poor manual bonding of the defective product) was removed from the firm's accepted supplier list; this action does not assure that firm's written Purchasing Control procedures were improved in order to prevent a similar incident in the future with a different contractor.

Firm has reportedly required its present contractor to conduct 100% leak testing for its IV administration sets, but this requirement has not been documented as part of written Purchasing Control Procedures.

Truecare Biomedix respectfully submits that a misunderstanding occurred regarding the statement above. Truecare Biomedix does not require 100% leak testing, nor does this occur at any of our supplier sites. To clarify the intended statement, our current main supplier, (b)(4), does perform 100% (b)(4) testing on the IV sets with flow regulators to ensure the flow regulators do not block fluid movement throughout the tubing. This is an internal requirement for (b)(4) and not a Truecare Biomedix requirement. Any statements made or misconveyed were in no way meant to be misleading or mischaracterize the testing performed on the IV sets.

Our representatives are aware that the clarity of these statements should have been defined during the audit close-out session.

For clarification to Truecare Biomedix analytical requirements and purchasing controls, the following actions have been enacted:
 

 

WL#  Action  Status 
4b  CAPA plan CAR 14-004-B was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified. In-process, see Attachment 26 
4b  Supplier Evaluation and Monitoring requirements are provided for in SOP-001  Complete, see Attachment 3 
4b  Purchasing is provided for within the updated purchasing requirements defined in SOP-002 Complete, see Attachment 4 

WL 5

Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example:

 

Your firm's Design Control SOP-015, dated 11/15/2012, does not include a requirement for design validation including risk analysis. Your firm has documented a specific risk analysis in Spanish; however an English version was not available during this present FDA inspection. Your firm has no other documented design validation for its IV administration sets including labeling.

We acknowledge receipt of your revised Design Control Procedures, SOP-003, however your written response remains inadequate because you failed to provide an English version of your risk analysis and design validation for your IV administration sets.

Truecare has endeavored to further improve Design Control by taking the following steps:

 

WL#  Action  Status 
CAPA plan CAR 14-006 was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified. In-process, see Attachment 27 
SOP-003, Design Control, has been generated and includes risk analysis provisions Complete, see Attachment 28 
Provide translation of the Risk Assessment in English and updated Complete, see Attachment 29 
SOP-020, Process Risk Analysis was generated to provide instruction for risk assessment Complete, see Attachment 30 

WL 6

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 2 1 CFR 820.30(i). For example:

 

Your firm's Design Control SOP-015, dated 11/15/2012, does not include what methods are used to control design changes.
 

We acknowledge receipt of your revised Control of Design and Process Changes SOP-004 procedure. We cannot determine the adequacy of your response, dated October 6, 2014, at this time and can only determine your adherence to your stated methods for design control changes through a follow up inspection.

Truecare acknowledges that Design Control is a major requirement for evaluating current and prospective suppliers, and a detailed evaluation can be found in the Supplier Audit Checklistan example can be found in the      (b)(4) audit, refer to Attachment 13.

As a commitment to quality documentation and change control, Truecare has enacted these further improvements in addition to the initial SOP revision:

 

WL#  Action  Status 
CAPA plan CAR 14-007 was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified. In-process, see Attachment 31 
SOP-004 for Control of Design and Process Changes has been generated. The further updated version of SOP-004, Change Control for Finished Products and Processes was modified to clarify the title
 
Complete, see Attachment 32 
QF-014 was generated for Engineering Change requests  Complete, see Attachment 33 
SOP-003, Design Control was established and updated   Complete, see Attachment 28 
All purchase orders include the following statement: By acceptance of this Purchase Order, supplier assures that all products will be strictly produced according to US CFR21:820, CE and ISO13485. All products manufactured for Truecare Biomedix(TCB) will be according to TCB specifications. No component or raw material substitutions may occur without prior notification and approval from the President of Truecare Biomedix. Complete, see Attachment 52 

 

 

 

 

WL 7

Failure to review, evaluate, and investigate complaints by a designated unit, as required by 21 CFR 820.198(a). Specifically,

 

 

a) Your firm's Complaint procedures (Product Complaint Processing SOP-044, dated 11/15/2012, and Product Reporting SOP-002, dated 11/15/2012) do not include requirement that complaint investigation include identification of most likely underlying cause.
 

Truecare acknowledges that the Complaint procedure was not sufficient and has taken the following actions:
 

 

WL#  Action  Status 
7a  CAPA plan CAR 14-008-A was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified. In-process, see Attachment 34 
7a  SOP-012, Customer Complaints, was generated and updated Complete, see Attachment 35 
7a  SOP-018, Medical Device Report (MDR), was generated Complete, see Attachment 36 
7a  QF-018-1 FDA Reportable Complaints was generated in order to assist with decision making Complete, see Attachment 37 
7a  A Master Complaint and MDR Tracking log was generated Complete, see Attachment 38 
7a  SOP-019 Quality Investigations was generated   Complete, see Attachment 39 
7a  A QF-012-1 Complaint Investigation Form was generated  Complete, see Attachment 40 

b) Your firm received 3 complaints in 2012 regarding IV administration sets which were found to leak at the junction between tubing and the luer lock. The firm has not documented attempts to obtain full details (nature of complaint) in that they did not document attempt to determine if patients were involved in the incidents in the complaints or if medical intervention was required for any patients as a result of the IV administration sets leakage.

We acknowledge receipt of your revised procedure, Customer Complaints, SOP-012, however your response is inadequate. For example, you state in your written response that your firm maintains documentation regarding the status of the patients referred to in the three complaints, however you (1) failed to provide supporting documentation with your written response to substantiate that your firm attempted to determine whether medical intervention was required for any of the patients involved in the incidents involving IV administration sets leakage (2) nor did you provide a rational for why this information was not provided to our investigator during the course of your inspection.

With regards to the two statements listed above, labeled (1) and (2) for referencing, Truecare Biomedix acknowledges the following points:

(1) Deficiency in the Customer Complaint procedure, specifically appropriate documentation of any incoming complaints. We have taken steps to rectify this deficiency with review and revision of SOP-012 (refer to Attachment 35).

(2) Inadequate documentation and follow-up at the time of the events in question hindered an appropriate response or rationale during the audit. Since this time, the following actions have occurred:

 

A. We believe an appropriate procedure is now in place to control the complaint process and offer thorough documentation of these events

B. MedWatch documentation on the first two (2) complaints in question, revealed that no injury resulted, particularly since these events occurred while preparing the IV sets for use and prior to the patient's use of the device.

C. Truecare Biomedix has contacted the nurse who reported "leaking at the junction between the tubing and the luer lock" event dated July 26, 2012 to follow-up and define the outcome of the event for the patient. The request was rebuffed and future attempts to request information were disinvited.
 

In addition to the response from 7b given above, Truecare acknowledges the actions taken at the time of the complaints for follow-up and reporting were not sufficient and has taken these further steps:
 

 

WL#  Action  Status 
7b  CAPA plan CAR 14-008-B was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified.
 
In-process, see Attachment 41 
7b  SOP-018, Medical Device Report (MDR), was generated
 
Complete, see Attachment 36 
7b  QF-018-1 FDA Reportable Complaints was generated in order to assist with decision making
 
Complete, see Attachment 37 
7b  A Master Complaint and MDR Tracking log was generated
 
Complete, see Attachment 38 
7b  The 3 attached MDR complaints were filed on December 10, 2014 using Form FDA 3500A
 
Complete, see Attachment 42 
7b  QF-012-1, Complaint Investigation, forms were completed for each of the filed MDR complaints  Complete, see Attachment 54 

WL 8

Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example:

Document control procedures have not been adequately established. Your firm's Control of Documents SOP-005, dated 11/15/2012, does not include method of how firm will control non-approved (draft) or obsolete documents.

We acknowledge receipt of your newly established procedure for Control of Documents, SOP-005. However we can only determine your adherence to your stated document control procedures through a follow up inspection.


Truecare acknowledges that the document control procedure was not sufficient and has taken the following actions:

 

 

 

 

WL#  Action  Status 
CAPA plan CAR 14-010 was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified.
 
In-process, see Attachment 43 
SOP-005, Control of Documents was updated to include control of obsolete documents
 
Complete, see Attachment 44 

 

 

Our inspection also revealed your firm's IV administration set 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 regarding the device, as required by Section 519 of the Act, 21 U.S.C. 360(i), and 21 CFR 806 - Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

WL 9

Failure to submit any report required by 21 CFR 806.10(a) within ten working days of initiating a correction or removal, as required by 21 CFR 806.10(b). For example, on or after July 18, 2012, your firm generated a Return Material Authorization for defective IV administration sets, part number MS721. On November 2, 2012, your firm emailed (b)(4), informing them that US Infusion directed trucks to sites to pick up recalled product. The devices were removed due to leaking at they-site. Your firm's action has been reviewed by FDA and determined to meet the definition of a Class II recall, which also meets the risk to health threshold for a 21 CFR 806 report, as specified in 21 CFR 806.2(k)(2). Therefore, your firm's actions should have been reported to FDA within ten days, as required by 21 CFR 806.10(b). You did not notify the FDA, in writing, within ten days of initiating this removal.


In 2012, Truecare Biomedix was notified of the complaints by Medical Specialties Distributors (MSD). During discussions between the two parties, the decision to recall Medstream 81" (206 cm) 20 drop Universal Administration Sets, MS721, Lot 20111115 was made jointly by Truecare Biomedix and MSD representatives. It was agreed that MSD would handle recall activities. FDA was notified of the removal of Medstream 81" (206 cm) 20 drop Universal Administration Sets, MS721, Lot 20111115 by MSD in 2012 (See Attachment 45). Truecare does acknowledge that allowing MSD to handle the recall was not the the correct course of action and Truecare Biomedix intends to handle any future recalls directly.

Since that time, Truecare Biomedix has taken the following actions:
 

 

WL#  Action  Status 
Truecare Biomedix formally notified FDA of its intent to recall on December 11, 2014   Complete, see Attachment 46 
SOP-011, Device Recall and Advisory Notices was established and recently revised
 
Complete, see Attachment 47 
A Health Hazard Evaluation worksheet was generated  Complete, see Attachment 48 
A Return Material Reconciliation form was generated
 
Complete, see Attachment 49 
Recalled product was disposed of in accordance with state and local requirements, with the exception of one box of IV administrations sets (retained for investigational purposes).
 
Complete, see Attachment 24 
Truecare Biomedix has requested that MSD terminate the 2012 recall of Medstream 81" (206 cm) 20 drop Universal Administration Sets, MS721, Lot 20111115
 
Complete, see Attachment 57 


WL 10

Failure to report to us no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned, and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21CFR 803.50(a)(2).

For example, your firm has not reported three complaints related to a recall in 2012 due to leakage from its IV administration sets which had potential to harm patients as MDR Malfunction reports to FDA.

Your response, dated October 6, 2014, is inadequate in that you failed to adequately address the three known complaints related to your IV administration sets leakage and did not provide supporting documentation that you intend to report them. We disagree with your assertion that a severe malfunction could not go undetected by medical staff and that it is unlikely that such a malfunction could ever progress to serious injury or death. FDA has not received the MDRs for the referenced complaints. You should immediately correct this deficiency.


Truecare acknowledges that a report should be made to the FDA within 30 days. Please note that Truecare Biomedix terminated the contract with (b)(4) Company Limited as of August 16, 2012 as well as implementing the following actions:
 

 

WL#  Action  Status 
10  CAPA plan CAR 14-002 and CAR 14-011 were established to plan corrective and preventive actions. CARs will be in-process until the effectiveness is verified. In-process, see Attachment 50 
10  SOP-012, Customer Complaints, was generated and updated  Complete, see Attachment 35 
10  SOP-018, Medical Device Report (MDR), was generated  Complete, see Attachment 36 
10  QF-018-1 FDA Reportable Complaints was generated in order to assist with decision making Complete, see Attachment 37 
10  A Master Complaint and MDR Tracking log was generated   Complete, see Attachment 38 
10  The 3 attached MDR complaints were filed on December 10, 2014 using Form FDA 3500A Complete, see Attachment 42 


WL 11

Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. Specifically, written MDR procedures have not been developed.

We acknowledge receipt of your revised procedure to address MDR Reporting in your SOP-011, Device Recall and Advisory Notices and the associated MDR Reporting Checklist, QF-011. Your revised procedure and checklist are inadequate. For example:

In your response to FDA 483 Observation 2, you state you "have read the instructions for filing FDA 3500A ... and now understand that the reporting requirements include situations where there was a malfunction of the equipment and that such malfunction "would like to cause or contribute to a death or serious injury if the malfunction were to recur." Your response to FDA 483 Observation 2, is in conflict with your procedure and MDR Reporting checklist and as such is inadequate to comply with the reporting requirements. Your MDR Reporting Checklist, QF-011 does not take into account your purported new understanding of the reporting requirements.


Truecare has taken the following actions to remedy the situation in addition to eliminating QF-011:
 

 

WL#  Action  Status 
11  CAPA plan CAR 14-009 was established to plan corrective and preventive actions. CAR will be in-process until the effectiveness is verified. In-process, see Attachment 51 
11  SOP-018, Medical Device Report (MDR), was generated Complete, see Attachment 37 
11  QF-018-1 FDA Reportable Complaints was generated in order to assist with decision making Complete, see Attachment 38 
11  A Master Complaint and MDR Tracking log was generated Complete, see Attachment 39 

To conclude our response, Truecare Biomedix remains committed to providing the highest quality products to its customers, and to maintaining a vigilant approach to compliance with all applicable regulations. We believe that the improvements detailed in this response will address the concerns identified by the Agency, and add clarity to certain areas of our quality systems and practices.