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o The Initial Field Alert Report (FAR) shall include an assessment of the cause of the event based on e
µ.formation available at the time.

o If the initial rapid communication did not include transmittal of the information via the current version of
Form FDA 3331, the Regulatory Head - US (or designee) will follow up the ifHtja l comrowiication m writing
1
v-i
submission of FDA Form 3331(refer Attachment - II) to the FDA District Oftce.

o Commitments made must be documented and tracked to cpmpletlox!I. and made available to the FDA.if
'
requested.

o A follow-up Field Alert Report (FAR) will be subrnitted by ipe Regulatory Head US to the FDA every thirty (30)
calendar days until the investiga tion is completed and the Final FJ'i.R is filed

o The follow-up FARs shall identif y the progrss m,ad in the investigation.

o The Final Field Alert Report (FAR) will be submitted by Regulatory Head - US to the FDA. not more
than ftve (5) working days upon receipt of lthe concluded! (finahzed investigation report from the
n1anufactunng sites

o If there is an unforeseen delay that is encountered to sub1nit the final report within five (5) working days,
tills incident shall also be documented in the RJeld Alert f ina l epott.

o Drug Safety/Pharmacovigilance (PVG) /Medical A ff aus may perforn1a Health Haza rd Evaluation (HHE) to
assess the impact of the quality event egardi1ig tbEI dentJty, safety.PQllty; strngth. a111.d quatity of U1e
product for patient safety
 o Include the assessment summnry m n the f'1ld 1Jt;lrt eport (t'AH) consp91d,
' nq t9 th FDA, as submitted by
Regulatory Af ------- ---- ---- -----......_...
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