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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Osachi Co. Ltd. 11/13/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993
 

WARNING LETTER

NOV 13, 2012

 
VIA UNITED PARCEL SERVICE

 
Mr. Yasuyuki Yaguchi
President
Osachi Co. Ltd.
9-11, Osachi Kohagi 2-Chrome
Okaya-Shi, Nagano, Japan
 
Dear Mr. Yaguchi:
 
During an inspection of your firm located in Okaya-Shi, Nagano, Japan, on August 6, 2012, through August 9, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures non-invasive blood pressure monitors (PADCHEK  ABI/PVR).  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 function of the body. 

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from you dated August 17, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which 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 adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). 

For example: Your firm’s current  Corrective and Preventative Action (CAPA) procedure, Doc. No. 030, Version B-2.20, does not include the following two requirements for:

a.  Verifying and validating the corrective and preventive action to ensure that such an action is effective and does not adversely affect the finished device; and

b.  Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems. 

The adequacy of your firm's response cannot be determined at this time.  Your firm states in its response that it is currently working to complete all corrections by November 6, 2012, as specified on the annotated FDA 483.  Consequently, your firm has not included a description and evidence of implementation of a correction, corrective action, or a systemic corrective action.

2. Failure to maintain adequate complaint files and 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: Your firm’s Customer Complaint Handling SOP, Defect Report Notification, Doc. No. 029, Version B-1.10, and your firm’s complaint handling form do not require that complaints be evaluated to determine whether the complaint represents an event that is required to be reported to FDA under 21 CFR 803, Medical Device Reporting. 

The adequacy of your firm's response cannot be determined at this time.  Your firm provided an updated Complaint Handling SOP and Complaint Handling form during the inspection; however, the version was not translated.  Additionally, your firm states in its August 17, 2012, response that it is currently working to complete all corrections by November 6, 2012, as specified on the annotated FDA 483.  Consequently, your firm has not included a description and evidence of implementation of a correction, corrective action, or a systemic corrective action.

3. Failure to establish and maintain adequate procedures for verifying the device design, to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f). 

For example: Your firm’s design verification raw data sheets for (b)(4) tests, and your firm’s verification summary report did not contain the date and signature of the individuals performing or reviewing the verification activities. 

The adequacy of your firm's response cannot be determined at this time.  Your firm states in its response that it is currently working to complete all corrections by November 6, 2012, as specified on the annotated FDA 483.  Consequently, your firm has not included a description and evidence of implementation of a correction, corrective action, or a systemic corrective action.

4. Failure to establish and maintain adequate data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 CFR 820.50(b). 

For example: Your firm’s purchasing documentation for the (b)(4) that is used in the PADCHEK ABI/PVR non-invasive blood pressure monitor does not include an agreement with its contract manufacturer, (b)(4), which requires its supplier to notify  your firm of any changes to the supplied component.

The adequacy of your firm's response cannot be determined at this time.  Your firm states in its response that it is currently working to complete all corrections by November 6, 2012, as specified on the annotated FDA 483.  Consequently, your firm has not included a description and evidence of implementation of a correction, corrective action, or a systemic corrective action.

5. Failure to adequately document acceptance activities, as required by 21 CFR 820.80, as required by 21 CFR 820.80(e). 

For example: Your firm’s incoming, in-process, and finished product acceptance records for (b)(4) product lots, which were distributed in the U.S., are missing documentation of the equipment used for acceptance testing. 

The adequacy of your firm's response cannot be determined at this time.  Your firm states in its response that it is currently working to complete all corrections by November 6, 2012, as specified on the annotated FDA 483.  Consequently, your firm has not included a description and evidence of implementation of a correction, corrective action, or a systemic corrective action.

6. Failure to establish and maintain adequate procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record and the requirements of 21 CFR 820, as required by 21 CFR 820.184. 

For example: Your firm’s DHRs for (b)(4) product lots, which were distributed in the U.S., do not contain primary labels or labeling information, or do not refer to the location of the labeling information. 

The adequacy of your firm's response cannot be determined at this time.  Your firm states in its response that it is currently working to complete all corrections by November 6, 2012, as specified on the annotated FDA 483.  Consequently, your firm has not included a description and evidence of implementation of a correction, corrective action, or a systemic corrective action. 

Our inspection also revealed that your firm’s non-invasive blood pressure monitor device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting.  Significant violations include, but are not limited to, the following: 

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.

For example: Your firm has no written MDR procedures. 

The adequacy of your firm's response cannot be determined at this time.  Your firm states in its response that it is currently working to complete all corrections by November 6, 2012, as specified on the annotated FDA 483.  Consequently, your firm has not included a description and evidence of implementation of a correction, corrective action, or a systemic corrective action. 

Given the serious nature of the violations of the Act, the non-invasive blood pressure monitoring devices manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated.  As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected.  In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.  We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. 

Also, U.S. 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 deviations are reasonably related will not be approved until the violations have been corrected.  Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected. 

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, including 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.  Please provide a translation of documentation not in English to facilitate our review. 

Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #362438 when replying.  If you have any questions about the contents of this letter, please contact: Joshua Simms at 301-796-5599.

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 yours,

/S/                                                                           
                                                                   
Steven D. Silverman 
Director
Office of Compliance
Center for Devices and 
  Radiological Health
      

 

 

CC:
     US Agent
     James R. Greenwood, PhD
     PADTest, LLC.
     23705 S. Desert Sands Drive
     Chandler, AZ 85248