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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Horiba Instruments, Inc dba Horiba Medical 7/25/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415 

 WARNING LETTER

 
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
 
July 25, 2012 
WL 31-12
 
Nobuhiro Tanji, Acting Vice President/Executive Assistant
Horiba Instruments, Inc., dba Horiba Medical
34 Bunsen Drive
Irvine, California 92618
 
Dear Mr. Tanji:
 
During an inspection of your firm located in Irvine, California, on February 15, 2012 – March 1, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ABX Micros 60 Hematology Analyzer and ABX Micros 60 IM2 (also referred to as the ABX Micros 60 IM). Also, your firm is an own-label distributor and importer of the ABX Pentra 400 Clinical Chemistry Analyzer and the ABX Micros 60 Hematology Analyzer. 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.
 
Our inspection revealed that the ABX Micros 60 IM2 is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).  For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency.  [21 CFR 807.81(b)]  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
Our inspection also revealed that your firm’s ABX Micros 60 IM2 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 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, failure to provide justification for not reporting a correction or removal action to FDA, which shall contain conclusions and any follow-ups, and be reviewed and evaluated by a designated person, as required by 21 CFR 806.20(b)(4). 
 
For example, your firm’s SOP for corrections and removals, SOP-0078, Rev: 5, gives Horiba Medical, Irvine, the responsibility to ensure that any of the manufacturing sites listed therein perform the record keeping, reporting, and other activities required by 21 CFR Part 806. The corrections relating to the Minotrol 16 Creatinine devices were not reported to FDA and there is no documented justification for this reporting failure.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide a copy of the revised procedure SOP-0078 or documentation of training on the procedure. In addition your firm’s response did not explain why corrections were not reported to the FDA regarding the Minotrol16 Creatinine devices.
 
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.
 
This inspection also revealed that the devices noted above 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 Carl Levine, Director of Service and Compliance, dated March 22, 2012, 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 control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). 

 
For example, the ABX Micros 60 IM2 was designed at your firm’s Irvine, California, facility; however, design control procedures have not been established. 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include any information regarding a systemic corrective action to include a retrospective review of other products to ensure that design controls were documented and completed as required. In addition, your firm did not provide a copy of SOP-0098 and documentation of training on this procedure.  
 

2. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). 

 
For example, the validation of ABX Micros 60 IM2 is deficient, in that it lacks the identity of the Micros (b)(4) analyzer, (b)(4), (b)(4) and (b)(4) required. The protocol/report dated 6/18/2007 has two columns for reporting pass/fail, but only one column was completed and there was no summary or conclusions in the final report. Upon request by the investigator, Mr. (b)(4) (your firm’s Director of Service and Compliance) indicated that your firm did not have a summary conclusion other than (b)(4) confirming that the validation was completed successfully. This was documented by sending Horiba Medical the released version.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any data for validation of the ABX Micros 60 IM2 by Technidata.
 

3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). 

 
For example, your firm’s CAPA Procedure, SOP-0073, Revision 6, Implementation Date 12/16/2005, was not adequately implemented, in that it references internal CAPA databases that are no longer used. Moreover, monthly CAPA committee meetings required by the procedure have not occurred.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include any information showing a systemic corrective action. In addition, a copy of SOP-0073, documentation of training on the procedure, and the outcome of the retrospective review of SOP-0073, Corrective and Preventive Action Procedure, and SOP-0008, Customer Complaints Procedure, were not provided.
 

4. Failure to validate computer software adequately for its intended use according to an established protocol, as required by 21 CFR 820.70(i).

 
For example, there is no protocol and documentation to demonstrate that the software used to produce (b)(4) for the ABX Micros 60 IM2 has been validated.
 
We reviewed your firm’s response and concluded that it is not adequate. Your firm’s response does not include any information including a systemic corrective action. In addition a copy of the validation protocol and results of the outcome of the retrospective review of software used to produce (b)(4) for the ABX Micros 60 IM2 was not provided.
 

5. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). 

 
For example, your firm has not established procedures for documenting and controlling nonconforming product.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include a systemic corrective action. In addition the firm did not provide a copy of SOP-0008 and SOP-0049 and documentation of training on the protocols was not provided.
 

6. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). 

 
For example, complaint procedure Customer Complaint Doc Number CORP-NUM-0064, Revision 6, Implementation Date: 06/26/2009, requires reporting of problems relating to the performance characteristics of devices as complaints. A review of more than 15 service reports selected from the (b)(4) characteristics of devices were reported as service reports and not complaints.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include a systemic evaluation regarding the corrective action. In addition your firm did not provide a copy of SOP‑0008, documentation of training on the protocol, and the outcome of the retrospective review of service reports dated back to January 2010.  
 

7. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). 

 
For example, your firm indicated that it has not established procedures for acceptance of incoming products.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include a copy of SOP-0048, SOP-0049, FCD-0020, and FDC-0085, documentation of training on the procedures, and the outcome of the retrospective review of products received since January 2010.
 

8. Failure to adequately review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures, and to document the dates and result of the quality system reviews, as required by 21 CFR 820.20(c). 

 
For example, SOP-0035, Management Review, Revision 6, implementation date of 12/13/2005, has not been adhered to in that the SOP requires quarterly reviews. According to Mr. (b)(4), your firm does not have documentation that management reviews have been conducted.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include a systemic corrective action. In addition a copy of SOP-0035 and documentation of training on the procedure was not provided.
 

9. Failure to establish and maintain procedures for quality audits and to conduct audits to assure that the quality system complies with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. 

 
For example, your firm has not established a procedure for conducting quality audits and no quality audits has been performed.  
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response does not include any information regarding a systemic corrective action. In addition your firm did not provide a copy of SOP-0033, training documentation on the procedure, and the reestablished regular audit schedule for fiscal year 2012 (January to December).
 

10. Failure to establish and maintain device master records as required by 21 CFR 820.181. 

 
For example, there is no device master record for the ABX Micros 60 IM2, including labeling specifications, component specifications, and software specifications.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide a copy of SOP-0074, the device master record, documentation of training on the procedure, and the outcome of the retrospective review of products applicable to Device Master Regulations and shipped since January 2010.
 

11. Failure to maintain adequate device history records as required by 21 CFR 820.184. 

 
For example the device history record is inadequate in that there are no acceptance records for the ABX Micros 60 IM2 units, as stated by Mr. (b)(4).
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not include a copy of device history record procedures, documentation of training on the procedures, and the outcome of the retrospective review of devices shipped since January 2010 for conformance to the new procedure.
  
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 (including any systemic corrective actions) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your firm’s response should be sent to: Blake Bevill, Director, Compliance Branch. Refer to the Unique Identification Number 289898 when replying. If you have any questions about the contents of this letter, please contact: Ms. Mariza Jafary, Compliance Officer at 949-608-2977.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Inspectional Observations, FDA 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/                                                   
Alonza E. Cruse, Director

Los Angeles District