Post on 13-Jul-2020
transcript
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
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
InternationalOrganization
Management OUS
Mfg OUS OPS OUS
RA/QA OUSManagement 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
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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
Sales people work out of this office ◦ Sometimes get report of an adverse event
Ad hoc activity on how this gets handled
Investigation is thwarted ◦ Time zone
◦ Language
◦ No gathering of initial information
FDA Inspector came to inspect manufacturer
No procedures available and had to wait until day 2 to get SOPs
SOPS not in English so they were verbally translated by the General Manager
No records showing any type of investigation
Investigator had to wait for copy of compliant files and they were not in English
Response contains a real solution to the handling of adverse events
Exemption from filing an MDR
Communication with the District office and Office of Compliance
DITTO