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