- U S Infusion, Inc. dba Truecare Biomedix-USA
- Issuing Office:
- Florida District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Florida District|
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700 Fax: 407-475-4770
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
November 24, 2014
Marc I. Parness, President/CEO
US Infusion, Inc. dba Trucare Biomedix-USA
6356 Manor Lane, Suite #103
South Miami, FL 33143
Martin R. Dix, Attorney
106 East College Avenue, Suite 1200
Tallahassee, FL 32301
Dear Mr. Parness:
During an inspection of your firm located in South Miami, Florida on September 11-17, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer, distributor, and importer of intravenous (IV) administration sets (Class II device) that you contract for the manufacture thereof. Your firm was also identified to be an importer/own label distributor of IV poles (Class I device), and syringes (Class II device). 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 that your IV administration set 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 October 6, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that 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 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.
b) Your firm receives Certificate of Sterilization from its current IV administration set contractor which states in part that 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.
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.
The adequacy of your firm’s 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.
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.
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 CFR 820.100(a)(1).
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.
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.
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.
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 21 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.
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.
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 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 nor did you provide a rationale for why this information was not provided to our investigator during the course of your inspection.
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.
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:
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 the y-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.
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 21 CFR 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.
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 be likely 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.
A follow up inspection may 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/or 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 awarding of contracts.
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, 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.
Please send your response to the attention of Randall L. Morris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderely Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issue in this letter, you may contact Mr. Morris via telephone at (407) 475-4741 or via email at Randall.Morris@fda.hhs.gov
Finally, you should know that this letter is not intended to be an all-inclusive list of 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 FDA 483 issued at the close out of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance 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.
Elizabeth W. Ormond
Acting Director, Florida District
Company Response Letter
Close Out Letter