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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Global Medical Holdings LLC 10/12/12

  

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

Public Health Service
Food and Drug Administration
 
Kansas City District
Southwest Region
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100 

 

October 12, 2012
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
 
Ref. – KAN 2013-1
 
Daniel C. Bunting, President
Global Medical Holdings LLC
26378 289th Place
Adel, IA 50003
 
Dear Mr. Bunting:
 
During an inspection of your firm located in Adel, Iowa from August 22 through September 6, 2012, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures respiratory therapy devices. Under section 201(h) [21 U.S.C. §321(h)] of the Federal Food, Drug, and Cosmetic Act (the Act), 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) [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 Requirements (cGMP) of the Quality System Regulation found at Title 21 Code of Federal Regulations (CFR), Part 820. We received a response from (b)(4), Regulatory and Quality Consultant 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 review, evaluate, and investigate complaints related to the possible failure of a device to meet any of its specifications as required by 21 CFR 820.198(c). For example, you did not investigate complaints for the Aeroneb Go, 310G Mini CTOX, or 605 VacuMax when complaint descriptions included potential failure of the devices.
 
We reviewed your firm’s response and conclude that it is not adequate because while you state (b)(4) investigations and corrective actions will still be initiated per quality goals, you do not include your approach to addressing the complaints which you have not investigated.
 
2.      Failure to review all complaints to determine if an investigation is necessary as required by 21 CFR 820.198(b). For example, you did not investigate complaints related to the 501 MaxiCompressor and 5055 SportNeb Express when they exceeded an internal (b)(4)% goal for rate of complaints.
 
We reviewed your firm’s response and conclude that it is not adequate because while you state (b)(4) investigations and corrective actions will still be initiated per quality goals, you do not include your approach to addressing the complaints which you have not investigated.
 
3.      Failure to include required information in investigations of reportable complaints as required by 21 CFR 820.198(d). For example, you have not performed an investigation into the 2010 MDR for your 605 VacuMax Aspirator which involved a patient death to determine if the device failed specifications or was related directly to the adverse event.
 
The adequacy of your firm’s response cannot be determined at this time.
 
4.      Failure to establish and maintain procedures for implementing corrective actions as required by 21 CFR 820.100(a). For example, you received complaints for potential device failures for your Aeroneb Go, 310G Mini CTOX, and 605 VacuMax and you have not made appropriate corrections to prevent further device failures.
 
We reviewed your firm’s response and conclude that it is not adequate because while you state (b)(4) investigations and corrective actions will still be initiated per quality goals, you do not address the open CAPA’s nor have you made appropriate corrections to prevent future occurrences.
 
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 (15) 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: Kansas City District Office at the above address. Refer to KAN 2013-01 when replyingIf you have any questions about the contents of this letter, please contact: Patrick L. Wisor, Compliance Officer at 913-495-5148 or Patrick.wisor@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 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/ 
John W. Thorsky                 
District Director
Kansas City District Office
 
Cc: Mr. Peter S. Button
      Swynson Limited
      Little Horsted
      Uckfield East Sussex
      TN22 5ES
 
     Mr. Bradley S. Welch, Operations Manager
     Global Medical Holdings LLC
     26378 289th Place
     Adel, IA 50003