connie hoy october 2013 - fdanews mfg ous ops ous ra / qa ous management rep marketing ous ......

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  • Connie Hoy

    October 2013

  •  Warning letter issued to firm for complaint handling

    ◦ Failure to report within 30 days

    ◦ Failure to implement adequate procedures

    ◦ Failure to establish standard review process

     No procedure on how to fill out a 3500A

     Compliant SOP did not contain the address to send the 3500A

     Failure to properly identify the designated unit

  •  No definition of a reportable event in the procedure

     No documentation on how the decision to report or not report is made

     No method for adequate follow up

     No corrective actions taken

     Failure to maintain adequate information in complaint files

  •  Not aware of regulations

     Intentionally didn’t file in order to hide serious adverse events

     Forgot

    http://www.google.com/url?sa=i&source=images&cd=&docid=eeFj5Qq7A98SYM&tbnid=ofsxAXWtQd-liM:&ved=0CAgQjRwwAA&url=http://en.clipart-fr.com/search_clipart.php?keyword%3Dhomer%26page%3D2&ei=pxRMUvbNKI7M9ASC34GwCg&psig=AFQjCNHByHmClnnD2KWVhbvs1UTtl22Spw&ust=1380804135732028

  • COMPANY BELIEVED THEY WERE IN COMPLIANCE

  •  Failure to report within 30 days  Failure to implement adequate procedures  Failure to establish standard review process  No definition of a reportable event in the

    procedure  No documentation on how the decision to

    report or not report is made  No method for adequate follow up  No corrective actions taken  Failure to maintain adequate information in

    complaint files

  • International Organization

    Management OUS

    Mfg OUS OPS OUS

    RA/QA OUS Management Rep

    Marketing OUS

    Engineering OUS

    Headquarters OUS

    Designated Unit OUS Doc Control OUS

  • US Operation

    Sales in USUS Call Center

    US Subsidiary

  • Subsidiary establishment listing

    was for “Manufacturer”

  •  Manufacturers of medical devices are required to report a device-related death, serious injury, or malfunction…within 30 days after becoming aware of the event.

     Manufacturers are required to establish and maintain files related to reportable events.

     Manufacturers must develop, implement, and maintain written procedures for reporting adverse medical device events.

  •  No agreement or procedure between the headquarters and the subsidiary that showed responsibility for complaints, adverse event investigation, reporting

  •  Complaint handling procedures did exist but only at the headquarters level ◦ Due to the time difference, the US office

    could not obtain the procedures until the 2nd day of the inspection

     US Call Center personnel were not aware of the existence of procedures

  •  Procedures were not written in English

    This is amajor prob lem

    And they got inaal skdjqo

    tyrueieop

    Poer ywuqtiv

  •  When US call center was asked what they do when they “become aware” of a potential adverse event they replied:

    ◦ I tell the General Manager (a sales person)

     When General Manager was asked for next step he replied:

    ◦ I email headquarters

  •  No AE Event files to review because they were located in a foreign country

     Took another day to get a list of investigated AE

     Took another day to get copies of the files

     Files were not written in English

  • Some of the Adverse events were filed late

    >30 days

  • What is the best way to prevent a warning letter?

  • DO NOT GET A 483

  •  Importer - Takes first title to devices imported into the U.S. An Initial Importer must have a U.S. address (21 CFR 807.40)

     Distributor means any person (other than the

    manufacturer or the initial importer) who

    distributes a device from the original place of

    manufacture to the person who makes the final

    delivery or sale of the device to the ultimate

    consumer or user.

  •  FDA Inspector came to facility expecting to find a manufacturer with meeting all Quality System and regulatory Requirements

     Importers and distributors may be able to obtain MDR exemption

  •  Apply for an MDR Exemption

    ◦ FDA may, upon written request or at its own discretion….grant to user facilities or

    manufacturers an exemption, variance,

    or alternative form of reporting from any

    or all of the reporting requirements……

    …Medwatch regulation(8)

  •  Complaint handling procedure in English ◦ Relationship with US office to Hq

    ◦ Role of US call center

    ◦ Role of Designated Unit

     Basic, documented training for Call Center / Sales people on adverse events

     Script of questions for obtaining immediate Information (form)

     Timeframe to report AE to designated unit

  •  Copy (paper or eCopy) of investigations

     21 CFR 820.198 (g)

     If a manufacturer's formally designated complaint unit is

    located outside of the United States, records required by

    this section shall be reasonably accessible in the United

    States at either: ◦ (1) A location in the United States where the manufacturer's

    records are regularly kept; or

    ◦ (2) The location of the initial distributor

  •  Designated unit in US office

     Procedures (English) for complaint handling and AE investigation

     Original files in US office ◦ Copy sent to HQ

  •  Jump into action ◦ Changed their establishment type

    ◦ Applied for an exemption from reporting

    ◦ Had the Designated unit (OUS) file the late MDRs

    ◦ Provided Corrective action with in 10 days

     SOPs in English defining a compliant process

     Form for collecting AE information during call point

     Training Records for Call Center

  •  Received an exemption from MDR Reporting

     Sent copy of the exemption approval to the District Office

  •  160 Days had passed since the initial 483 was issued

     145 Days had passed since the initial response was sent to the district office

  •  Corrective Action was insufficient

     Response was inadequate

    They were given an exemption for the very thing they now had received the

    warning letter

  •  When they received the exemption they should have: ◦ Sent a written reply to the District Office

    ◦ Asked for a meeting with the District Office

    ◦ Sent a written reply to the Office of Compliance

    ◦ Asked for a meeting with the Office of Compliance

    ◦ All of the above

  • This should have prevented the WL, right?

    Should they ask to have

    the WL Rescinded?

  •  Is receiving an exemption for MDR Reporting adequate corrective action? ◦ My opinion: NO

     The exemption is for MDR Reporting because FDA is not interested in duplicate reporting

     It is NOT an exemption from complying with the regulation itself ◦ This company was not in compliance with the

    regulations as stated in 21 CFR 820

  •  Doesn’t really matter who files the piece of paper to the FDA

     The most important tasks are: ◦ Adequate investigation of the AE

    ◦ Identifying the root case

    ◦ Taking corrective action / preventive action

    ◦ Correct management of reportable events

    ◦ Good documentation that is available to the FDA

  • Can these tasks be adequately performed by a designated unit that is

    OUS?

  • Well trained designated unit OUS

    Well defined process for investigation

    Well defined communication with the US office and the designated unit

    Adequate investigation leading to root cause and closure

    Availability of records to present to FDA (electronic)

    Link to Well Defined CAPA program

  •  Well trained designated Unit in US  Well defined process for feedback to

    headquarters  Well defined process for investigation  Well defined communication with the US

    office and the designated unit  Adequate investigation leading to root cause

    and closure  Availability of records to present to FDA

    (electronic)  Link to Well Defined CAPA program

  •  Designated Unit should remain OUS

    ◦ US office does not have appropriate technical capability to investigate

  •  US office is only a sales office and call center

     Sales calls come into the office ◦ Sometimes report of an adverse event