DURING AN INSPECTION OF YOUR FIRM I OBSERVED: 

DEPARTMENT OF HEALTH AND HlJl\,IAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISlRICT ADDRESS AND PHONE NUMBER 

1 0 9 03 New Ha mpshire Ave, Bldg71- 51 28 

Si l ver Spr i ng , MD 20 993- 0 0 02 

2 4 0-4 02 - 8906 

DATE(S) OF INSPECTION 

6/6/ 2 022 - 6/ 1 7 /20 2 2* FEI NUMBER 

30092 5 6939 

NAME AND TITLE OF INDIVI DUAL TO WHOM REPORT ISSUED 

Chris t i ne H. Lee, MD, cli nica l i nves tig ato r 

FIRM NAME 

Chris tine H. Lee, M. D. 

STREET ADDRESS 

1952 Bay Street, Ro yal Jub i l ee Hospital , 

Memo r i a l Pavili on CITY, STA TE, Z[P CODE. COUNTRY 

Vict o r i a, British Columbia, Ca nada, V8R 

1J 8 

TYPE ESTABLISHMENT INSPECTED 

Clinica l I nves t igato r 

This document lists observations made by the FDA representative(s) dtumg the inspection of yom facility. They are inspectional 

obseivations, and do not represent a final Agei1cy determination regarding your compliance. If you have an obje.ction regarding an 

obseivation, or have implemented, or plan to implement, co!l'ective action in response to an obse1vation, you may discuss the objection or 

action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. Ifyou have any 

questions, please contact FDA at the phone number and address above. 

OBSERVATION 1 

An investigation was not conducted in accordance with the signed statement of investigator and 

investigational plan. 

Specifically, 

For the 2014-01 and 2017-01 studies, human clinical studies of an investigational new drug, that you 

conducted under an IND, you failed to follow the protocols as follows. 

A. You failed to ensure that all subjects you emailed and dosed with study drn met all eligibility 

c1iteria for the studies. For study 2014-01 , you enrolled ub ·ects and dosed ubjects with study 

diug. For study 2017-01 , you enrolle ubjects with study diug. For each 

study, you enrolled and dosed with sh1dy diug one subject who failed to meet an inclusion criterion as 

follows. 

1. Subject in study 2014-01 did not meet inclusion crite1ion 4, in that you lacked 

documentation that the subject had a positive stool test for C. difficile within 60 days prior to 

enrollment. You documented the subject's most recent positive C. difficile stool test as ____ 73 

days prior to the date you enrolled this subject, on l--iiiiiiiiiiiiiiiiiiiii.:I You dosed subject with study diug on 

SEE REVERSE 

OF THIS PAGE 

EMPLOYEE(S) SIGNATURE 

Sherri N Rohlf, I nve s tig ato r Shem Nftmlr 

~r aa~ """ 06-17- "-"°"'-S 2D22 X 1.4 13 

DATE ISSUED 

6/ 1 7 /2022 

PAGE!of4PAGES FORM FDA ~83 (09108) PREVIOUS EDIDON OBSOLETE INSPECTIONAL OBSERVATIO S 
DEPARTMENT OF HEALTH AND HlJl\,IAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISlRICT ADDRESS AND PHONE NUMBER 

10903 New Hampshire Ave, Bldg71-5128 

Silver Spring, MD 20993- 0002 

240-4 02 - 8906 

DATE(S) OF INSPECTION 

6/6/2022 - 6/ 1 7/2022* FEI NUMBER 

3009256939 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Christine H. Lee, MD, clinical investigator 

FIRM NAME 

Christine H. Lee, M. D. 

STREET ADDRESS 

1952 Bay Street, Royal Jubilee Hospital, 

Memorial Pavilion CITY, STA TE, Z[P CODE. COUNTRY 

Victoria , British Columbia, Canada, V8R 

1J8 

TYPE ESTABLISHMENT INSPECTED 

Clinical Investigator 

.

2. Subject in study 2017-01 , who you emolled and dosed with study chug, did not meet 

inclusion criterion 2, in that the subject did not meet the protocol definition of recurrent C. difficile 

infection (CDI). The subject's second occurrence of CDI diarrhea began on nine weeks 

after completion of treatment for previous CDI, on _......,......_...,..The protocol required a recunence of CDI 

dianhea to start within eight weeks after completion of treatment for previous CDI to meet the definition 

ofrecunent CDI for study entJ.y. You enrolled subject 011 ____ nd dosed the subject with study 

chug on '-==== This subject completed the study. 

B. For two subjects (subject d subject who you enrolled into study 2014-01 and dosed with 

study diug, you failed to obtain the signatures of the subjects on inf01med consent fonns (ICFs) and 

instead used the subjects' legally authorized representatives (LARs) to obtain informed consent. The 

2014-01 protocol, section 6.2, requires all subjects to sign the ICF. Furthermore, inclusion criterion 11 

of study 2014-01 requires subjects to be willing and able to provide informed consent. 

C.On you dosed subject study 2014-01 with blinded study diug, batch 

iiiiiiiiiiiii-ll' which according to the packing slip from the sponsor, was intended for subject 

D. In study 2014-01 , for subjects and who you enrolled and dosed with study ch1.1g, you failed to 

obtain stool samples for C. difficile testing at the time you suspected reoccurrence of C. difficile 

SEE REVERSE 

OF THIS PAGE 

EMPLOYEE(S) SIGNATURE 

Sherri N Rohlf, Investigator Shem Nftmlr 

aa~ ~r""""-"°"'-S 06-17-2D22 X 1.413 

DATE ISSUED 

6/ 1 7/2022 

PAGE2of4PAGES FORM FDA ~83 (09108) PREVIOUS EDIDON OBSOLETE INSPECTIONAL OBSERVATIO S 
DEPARTMENT OF HEALTH AND HlJl\,IAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISlRICT ADDRESS AND PHONE NUMBER 

1 0 9 03 New Hampshire Ave, Bldg71- 51 28 

Si l ver Spr i ng , MD 20 993- 0 0 02 

2 4 0-4 02 - 8906 

DATE(S) OF INSPECTION 

6/6/ 2 022 - 6/ 1 7 /20 2 2* FEI NUMBER 

30092 5 6939 

NAME AND TITLE OF INDIVI DUAL TO WHOM REPORT ISSUED 

Chris t i ne H. Lee, MD, cli nica l i nves tig ato r 

FIRM NAME 

Chris tine H. Lee, M. D. 

STREET ADDRESS 

1952 Bay Street, Ro yal Jub i l ee Hospital , 

Memo r i a l Pavili on CITY, STA TE, Z[P CODE. COUNTRY 

Vict o r i a, British Columbia, Ca nada, V8R 

1J 8 

TYPE ESTABLISHMENT INSPECTED 

Clinica l I nves t igato r 

infection which was required by the protocol. You documented these subjects as treatment failures and 

then dosed them with open label study drng without testing their stool for C. diffic.ile. 

E. You dosed subject 

subject had taken antibiotics on the same morning prior to dosing. The protocol required you to confirm 

a 24-48 hour antibiotic washout period prior to dosing at visit 2. 

OBSERVATION 2

Failure to prepare or maintain adequate case histories with respect to obse1vations and data pertinent to 

the investigation. 

Specifically,

In the 2014-01 stud , for subject who you dosed with study drng on____and who completed 

the study on____ you documented the subject had been admitted to the hospital ..... ___.;;a for 

acute coronruy syndrome, but you lack documentation that you assessed this hospital admission for 

adverse events. You failed to enter into the subject's electronic case report form any serious adverse 

events or adverse events associated with this hospital admission. Subject ·eceived study dmg and 

completed the study. 

*DATES OF INSPECTION

6/06/2022(Mon), 6/07 /2022(Tue ), 6/08/2022(W ed), 6/09/2022(Thu), 6/10/2022(Fri), 6/13/2022(Mon), 

6/14/2022(Tue), 6/15/2022(\iVed), 6/16/2022(Thu), 6/17/2022(Fri) 

SEE REVERSE 

OF THIS PAGE 

EMPLOYEE(S) SIGNATURE 

Sherri N Rohlf, I nve s tig ato r Shem N ftmlr 

~r aa~ """ 06-17-"""°"'-s 2D22 X 1.4 13 

DATE ISSUED 

6/ 1 7 /2022 

PAGE 3 of4PAGES FORM FDA ~83 (09108) PREVIOUS EDIDON OBSOLETE INSPECTIONAL OBSERVATIO S 
DEPARTMENT OF HEALTH AND HlJl\,IAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISlRICT ADDRESS AND PHONE NUMBER 

10903 New Hampshire Ave , Bldg71- 5128 

Silver Spring , MD 20993- 0002 

240-402-8906 

DATE(S) OF INSPECTION 

6/6/2022 - 6/ 1 7/2022* FEI NUMBER 

3009256939 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Christine H. Lee , MD , clinical investigator 

FIRM NAME 

Christine H. Lee , M. D. 

STREET ADDRESS 

1952 Bay Street, Royal Jubilee Hospital, 

Memorial Pavilion CITY, STA TE, Z[P CODE. COUNTRY 

Victoria , British Columbia , Canada, V8R 

1J8 

TYPE ESTABLISHMENT INSPECTED 

Clinical Investigator 

SEE REVERSE 

OF THIS PAGE 

EMPLOYEE(S) SIGNATURE 

Sherri N Rohlf, Investigator Shem Nftmlr 

~r""""-"°"'-S aa~ X 06-17-2D22

1.413 

DATE ISSUED 

6/ 1 7/2022 

PAGE4of4 PAGES FORM FDA ~83 (09108) PREVIOUS EDIDON OBSOLETE INSPECTIONAL OBSERVATIONS 
The observations of objectionable conditions and practices listed on the front of this form

are reported:

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or

2. To assist firms inspected in complying with the Acts and regulations enforced by the

Food and Drug Administration.

Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides:

"Upon completion of any such inspection of a factory, warehouse, consulting

laboratory, or other establishment, and prior to leaving the premises, the officer or

employee making the inspection shall give to the owner, operator, or agent in charge a

report in writing setting forth any conditions or practices observed by him which, in his 

judgment, indicate that any food, drug, device, or cosmetic in such establishment (1)

consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has

been prepared, packed, or held under insanitary conditions whereby it may have become

contaminated with filth, or whereby it may have been rendered injurious to health. A copy

of such report shall be sent promptly to the Secretary."