DEPART!

\fi: NT OF HEALTH AND H UMAi' l SERVICES

FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION

6t h & Kipling St. (P . 0 . Box 2 5 08 7) 8/25/201 6 - 9/2/20 1 6*

Denver, co 80225 - 0087 FEJNUMBER

(303) 236 - 3000 Fax : (303) 236 - 3 1 00 3011 976853

NAME AND TITLE OF INDM OUAL TO WHOM REPORT ISSUED

Anne M. Szilagyi Qu ality Head and General Manager

F IRM NAME
' STREET ADDRE SS

BSO LLC 1 2860 W Cedar Dr St e 2 11

C ITY. STATE. ZIP CODE. COUfflRY TYPE ESTABLISHMENT INSPECTED

Lakewood, co 80228 - 1 97 1 St erile Drug Manu fact u rer

This docwuent lists observations made by the FDA representative(s) dwmg the inspection of your facility. They are inspectional
observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an
observation, or have implemented, or plan to implement, conective action in response to an observation, you may discuss the obj ection or
action w-ith the FDA representative{s) dwmg the inspection or submit this infonuation to FDA at the address above. If you have any
questions, please contact FDA at the phone ntllllber and address above.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1
Time limits are not established when appropriate for the completion of each production phase t o
assure the quality of the drug product .

Specifically , hold t ime studies have not been performed for(b){'f~ in-process stages of testosterone
pell ets and estradiol pellets.

1[ -(6H4Y l material is 1 -(6f<4> 1 fo r ~D)(4) 1 r -(6f<4> I

2. Pellets are stored in [ -(6f(4 y 1 for 1(D) (4) -(6f<4)l ~D) (4) 1~ atches have been
held for longer than ~~)J~} 1 Estrad iol 6mg lot 20160112 @1 sterilization date f-(6} 4) ] and
Testosterone 200m g lot 20160310@3 sterilization date r-(6 -(4)lwere stored for longer than (D) (4)
(D) <4n

OBSERVATION 2
There are no written procedures for production and process controls designed to assure that the
drug products have the identity, strength, quality, and purity they purport or are represented to
possess.

Specifically ,

1. Process va lidation has not been performed for the any of the four unique hormone pellets drug
products man ufactured on site . No procedu res are established for the ongoing period ic mon itoring
of the drug man ufacturing process .

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE
OF THIS PAGE
Zachary L St amm, I nvestigat or
Zachary A Bogorad, I nvest i gat or
_
X Zadlar( A Bogoracl
.._._..
...
Slgntdi: ZXNryA.IIaglcnd~
"""'" 9/2/20 1 6

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOLETE INSPECTIONAL OBSERVATIONS PAGE I OF3 PAGES
 DEPART!\fi: NT OF HEALTH AND H UMAi' l SERVICES

FOOD AND DRUG ADMINISTRATION

D ISTRICT ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION

6t h & Kipling St. (P . 0 . Box 25087) 8/25/201 6 - 9/2/20 1 6*

Denve r, co 80225 - 0087 FEJNUMBER

(303)236 - 3000 Fax : (303)236 - 3 1 00 3011 976853

NAME AND TITLE OF INDM OUAL TO WHOM REPORT ISSUED

Anne M. Szilagyi , Qu ality Head and General Manager

F IRM NAME STREET ADDRESS

BSO LLC 1 2860 W Cedar Dr St e 211

C ITY. STATE. ZIP CODE. COUfflRY TYPE ESTABLISHMENT INSPECTED

Lakewood, co 80228 - 1 97 1 St erile Drug Manufact urer

Drug Name Concentrations in mg

Testosterone 12 .S, 2S, 37.S, so, 62 .S, 70, 80, 87.S, 100, 112.S, 200
Estrad iol 6, 10, 12.S, 1S, 18, 20, 22, 2S, 37.S, so, 7S
Progesterone 2S, 3S, so, 7S
Anastrozole 6

2. Equ ipment qualifications have not been assessed for the ~15} (4} I
The (t!>:(4 l -(oH4r 1
testosterone as well as estradiol active pharmaceutical
ing red ients . No end point to the I -(b) (4) ,has been identified. You have not collected
data in support of t he efficacy and reprod uci bility of t he I -(b) 4) JThere are no
defined cr iteria for the end point of t he 1 (b (4f J

3. Equipment qualifications have not been assessed f or r -(or<4r l incubators model (o) ( 4)
Incubators are used to store environmenta l monitoring plates. No procedu res are established for
t he ongoing periodic mon itoring of laboratory eq uipment.

*DATES OF INSP ECTION

8/ 25/ 2016(Thu),8/ 26/ 2016(Fri),8/ 29/ 2016(Mon),8/ 30/ 2016(Tue),8/ 31/ 2016(Wed),9/ 02/ 201
6(Fri)
9/2{1!J16

IX Zachary L Stamm
Zad>ary l Stanm

lrwestigator

SiJned by: Zad>ary L. Stanm S

EMPLOYEE(S) SIGNATURE DATE ISSUED

SEE REVERSE
OF THIS PAGE
Zachar y L St amm, I nvestigat or
Zachary A Bogorad, I nvest i gat or
_
X Zadlar( A Bogoracl
.._._..
...
Slgntdi: ZXNryA.IIaglcnd ~
"""'" 9/2/20 1 6

FORM FDA 483 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS PAGE20F3PAGES