DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER OATE(S)OF INSPECTION
12420 Parklawn Drive, Room 2032 10/3/2023-10/10/2023*
Rockville, MD 20857 FEJNUMBER
3006210232
NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED
Arvind Kumar Sharma, Managing Director
FIRM NAME STREET ADDRESS
Fresenius Kabi Oncology Limited Village Kishanpura, Baddi, Tehsil
Nalagarh
CITY. STATE. ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED
Solan, Himachal Pradesh, 174101 India Drug Manufacturer
This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional
observations, and do not represent a final Agency detemiination regarding your compliance. If you have an objection regarding an
observation, or have in1plemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or
action with the FDA representative{s) during the inspection or subrit this infonnation to FDA at the address above. If you have any
questions, please contact FDA at the phone number and address above.
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:
OBSERVATION 1
Procedures designed to prevent microbiological contamination of diug products pmpo1ting to be sterile
are not established and followed.
1. Procedure SOP/CSP/0015 "Behavior and Aseptic Practices for Persons Working in Aseptic
Area" was not followed, because operators did not "Keep the entire body out of the th of
unidirectional airflow to minimize disrnption" while perfonning inte1ventions in the�
�RAES
during aseptic filling operations. For example:
CbTC
a. An operator was obse1ved repeatedly leaning over the sterile product 4 and Cb(4)l
• an
CbT(4l durmg T(4) • •
Cb ·1 mte1vention that occmTed fi·om L.:]"Jl4on August 29,
I
2023, until l•J(4l on August 30, 2023, to change the1CbY{ l tank during aseptic filling of
4
CbT<, Injection batchl (bY{-41
b. Operators were obse1ved reaching over open vials and the I Cb)l4l with the non-sterile
RABS Cb)� in th�B used to aseptically fill product during Cb>, Injection batch
Cb>< (disti·ibuted to the US market),
4
4l
{6)l Injection batch CbT<, and
CbH1 Injection batch! (bY{4j
C. Operators were obse1ved reaching over open vials with the non-sterile RABS1CbT<1 to
EMPLOYEE(S) SIGNATURE
SEE REVERSE Justin A Boyd, Investigator
OF THIS PAGE Anastasia M Shields, Investigator
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. 2000358686
$�10--10--2023
DATE ISSUED
10/10/2023
FORM FDA �83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS PAGE I of!O PAGES
