DEPARDIE!
IoT OF HEALTH AND H\IMAN SERVICES
FOOD AND DRUG ADMINISTRATION
OAT!($) OF INSPECTIOH
8050 Marshal l Drive, Suite 205
Lenexa, KS 662 1 4 06/24/2014 - 07/14/2014*
FEI NUU R
( 913 ) 495 -5100 Fax: (9 1 3 ) 495 - 5115
100051 1010
Indust Information : www . fda. ov/oc/indust
t.IMIE IIK:J Tl~ OF INDMOUAL TO \'lotiON REPORT ISSUED
F~~ Firouzan Massoomi , Pharmac Operations Coordinator
STMET AOOI'IESS
Nebraska Methodist Hos ital
CITY, STA Z'P C00E. COI..WTRY e St
INSPCT!O
Omaha, NE 68114-4 108 Producer of Sterile Dru Products
This doc~ment lists observations made by the FDA representative(s) during the inspection ofyour facili ty. They are inspectional
Ob5rvat~ons. and do .not represent a final Agency determination regarding your compliance. Ifyou have an objection regarding an
ob~rvat~on. or have Implement~. or plan to implement. corrective action in response to an observation. you may discuss the objection or
actiO~ With the FDA representattve(s) during the inspection or submit this information to FDA at the address above. Ifyou have any
quest tons. please contact FDA at the phone number and address above.
DURING AN INSPECTION OF YOUR FIRM I OBSERVED:
OBSERVATION 1
A septic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce
aseptic conditions.
Specifically,
You have failed to document cleaning of your "Clean Room" . including the cleaning of your IV hood [IDJ
and IV hood WI where you produce sterile drug products. (Sterile, non-shedding wipes and sterile
(b ) (4 ) are used).
. pounded Sterile Products, Intravenou s Pro~ng. effective 1/ 1990",
Specifically. "Com
states, in "The laminar flow hood shall be cleaned at the - a n d uring
the day IV Technician will document cleaning by signing the log next
to the hood. failed to conduct and document cleaning with a sporicidal agent.
Your records documenting cleaning of the IV hoods, bins. cart and shelving are deficient for the months
of(at a minimum) April. May and JU?e of2?~4. Records indicate t?is cleaning of the IV ho~s lland
&I is not documented on alWIIIbasts. Addttlonally, the form reqmres ' of Bms, Cart
and Shelving. This is not documented as required for the months of Apn and June of2014.
OBSERVATION 2
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
You have failed to conduct and document Environmental Monitoring in your IV rooms (where sterile
drug products are produced)
~o~l<ll aro.....r~
SEE REVERSE Eric M. Mueller, Investigator~
07/14/2014
OF THIS PAGE
P'IU!IIIO\JS EDITION OIIJOLETE INSPECTIONAL OBSERVATIONS PAGE I OF J PAGES
DEPARTME!\T OF HEALTH AND HUMAN SERVICES
CISTRm AOORESS AND PHONE NUMBE.R
FOOD AND DRUG ADMINISTRATION
8050 Marshall Drive, Suite 205
06/24/2014 - 07/ 14 / 2014*
Lenexa, KS 66214 ,.ei NUMIIEit
( 913 ) 4 95 - 510 0 Fax: ( 913 ) 495 -5115
1000511010
Industry Information : www.fda.gov/oc / industry
HAlo AND TITlE 01' INDIVIDUAl TO 'M10tol REPORT ISSUED
TO: Firouzan Massoomi, Pharmacy Operations coordinator
FIRM HAlo
STREET .t.DOR88
Nebraska Methodist Hospital 8303 Dodge St
CITY. STA~ liP COOl!. COUNTRY
TYPE ESTA81.1s.MHT IN-CUO
Omaha, NE 68114-4108 Producer of Sterile Drug Products
Specifically,
Environmental Monitoring is not conducted daily in areas where sterile drug products are produced.
Additionally, Your r ..s conducting surface sampling states Environmental Monitoring (EM)
will be conducted on a basis to monitor microbial bioburden of work surfaces to analyze for
trends for improvement. to test include: the IV room laminar hoods, chemo hoods, counters used
for checking IV s and pass-through cabinets and or window plates).
Your records (June 2013 to June 2014) indicate this required ~M sampling was not completed
in entirety for the months of7/ 13, 8/ 13, 9/ 13, 2/ 14, S/ 14 and ~itionally, raw data results for
surface sampling are not kept by your facility and could not be verified.
Lastly, Procedures and records do not exist for the environmental monitoring of your ISO S areas
(within your facility) and personnel monitoring of your operators on a daily basis covering all shifts.
OBSERVATION 3
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established,
written, and followed .
Specifically,
Smoke studies are not conducted or documented by your site to verify airflow patterns in the areas where you produce sterile
drug products. This failure includes airflow studies are not conducted and documented under static or dynamic conditions.
OBSERVATION 4
Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not appropriate for
the duties they perform.
Specifically,
Personnel producing sterile drug products are not_g_owned with sterile gown if!&_ (for example. non-sterile gowns, masks
I.WI.OYU!CI) IliON.'""-- I DA~~
SEE REVERSE Eric M. Mueller, Investigator ,Jfi~11412014
OF THIS PAGE
JNSPECflONAL OBSERVATIONS PMlli l C. J PAOU
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT AOORfSS ANO PHONE NUMIIER OATf(S) OF INSPCTION
8050 Marshall Drive, Suite 205 06 / 24/2014 - 07/14/2014 *
Lenexa, KS 66214 FEINUMIIER
(913) 495-5100 Fax: (913) 495-5115 1000511010
Industry Information: www . fda.gov/oc/industry
NAME AN0 TITU: OF INOIVIDUAL TO WHOM REPORT ISSUED
TO: Firouzan Massoomi, Pharmacy Operations Coordinator
FIRM NAME STREET AOORESS
Nebraska Methodist Hospital 8303 Dodge St
CITY. STATE. ZIP COOE. COUNTRY TYPE ESTABLISHMENT INSPECTED
Omaha, NE 68114-4108 Producer of Sterile Drug Products
and hair nets are used in the areas where you produce sterile drug products).
Additionally. your personnel have exposed skin around the eyes, head and neck area in your ISO 5 laminar airflow
hoods area while producing sterile drug products.
OBSERVATION 5
Testing and release of drug product for distribution do not include appropriate laboratory detennination ofsatisfactory
conformance to the final specifications prior to release.
Specifically,
You have failed to document a 100% visual check prior to distribution of your sterile finished drug products.
OBSERVATION 6
Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written and followed.
Specifically,
Specifically, sampling and testing of sterile finished drug products (for sterility/endotoxin) is not
conducted by your site prior to release for use.
Lastly, the potency ofyour sterile drug products is not supported by data for the shelf life claimed. No
data exists supporting the shelf life of your sterile drug products produced at this site.
* DATES OF INSPECTION:
06/24/20 14(Tue). 06/25/2014(Wed), 06/26/2014(Thu), 06/27/2014(fri), 07/03/2014(Thu), 07/09/2014(Wed), 07/14/2014(Mon)
EMPLOYEE(&) SIGNAT'UR OATe..-o
SEE REVERSE
OF THIS PAGE
Eric M. Mueller, Investigator
(pi{~ 07/14/2014
FORM FDA '13 (M/U) l'llEVIOUS I!.OITION OIISOI.En INSPECTIONAL OBSERVATIONS PAGE 3 Of') PAGES
