08/25/2015 - 09/16/2015*

3010479366

v/oc / indus t
Chief Executive

and Founder
Road

Inc.
Palo Alt o

CA

9 4 304-1111

Manufa cture r

This document lists observations made by the FDA representative(s) during the inspection ofyour tacility. They are inspectional
obsetVations, and do not represent a final Agency determination regarding your compliance. Ifyou have an objection regarding an
observation, or have implemented, 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 submit this infonnation to FDA at the address above. If you have any
questions, please contact FDA at the phone number and address above.

The observations noted in this Form FDA-483 are not an exhaustive listing ofobjectionable conditions. Under the law, your
firm is responsible for conducting internal self-audits to identify and correct any and all violations ofthe quality system
requirements.
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1

Design validation did not ensure the devi~ conforms to defined user needs and intended uses.
Specifically,

SEE RCVERSE
OF THIS PAGE

Seema S. Singh, Invest igator

Ian A. Pilcher, Investigator
!NSPECI'IONAL OBSERVATIONS

"09/16/2015

- 09/16/2015*

3010479 366

Palo Al t o

CA

9430 4 -1111

Man u f acturer

OBSERVATION 2

The design was not validated tmder actual or simulated use conditions.
Specifically,

were produced
the same specifications, production
be used for routine production. For example, you do not list
specific instruments or analyzers used, documents with revisions numbers used, or

OBS!CRVATION 3

Design input requirements were not adequately documented.

Specifically,

A.
inte:nd~:d to be
device to collect patient samples and have reported the results with at

OBSERVATION 4

Results ofthe design risk analysis were not adequately documented.

Specifically,

SEE REVERSE
OF THIS PAGE
FORM

Seema S. Singh, Investi gator

Ian A. Pilc h er, Invest ig~to~

~~
09/16/2015

- 09/1 6/2015*
301 0 47 9 3 6 6
Chief Executive
Inc .

Pa lo Alto

CA

and Founde r
Mill Road

9 430 4-11 11

B.

OBSERVATION 5
Docwnents were not reviewed and not approved by designated individual(s) prior to issuance .

Specifically,
A. ~0069 Revision A, provided as the hazard analysis for tb~cvices, was utilized from February
April2014. The document does not have an effective date. The document was not released in your document control
system until8/26115 (during the inspection). The document was not reviewed and approved prior to 8/26/15.

B.
,..ts were

........ uu...

conducted in 2014; however,

untU 9/10/ 15.
.....,,........ v ...

design

this inspection and were not reviewed and approved

C.
as a
your
document was
doc:um.e nt was drafted during the inspection. It has not been reviewed or approved until
9/ 10/ 15.

SEE REVERSE
OF THIS PAGE

Seema S . Singh, Investigator

I an A. Pilcher, I n vestigator
OI3SOI.Bll!

09/16/2015

DEPARTMENT Oio' HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMlNISIRATION
Co\TE(S) OF O'ISPECl10N

1 431 Harbor Bay Parkway

Alameda, CA 94502- 7070
(510) 337-6700 Fax: (510) 337-6702
Industry Information: www. fda . gov/oc/industry

08/25/2015 - 09/16/2015*
FEINUM!IER

301 0479 366

NAMEAN:l TITlE OF INOMDJAJ. TO w-tOM REPORT 188\lED

TO:

Elizabeth A. Holmes, Chief Execut ive Officer and Founder

I STREET""'-""""

ARIINAME

Theranos , Inc.

1701 Page Mill Road

CflY. STAll: . ZP CODE. <:<>~.Wlt<Y

1YPE ESTAS LISI6ENT INSPECTED

' Palo Al t o, CA

94304-1111

Manufacturer

Observation Annotations
Observation 1:
Observation 3:
Observation 5:

Reported corrected, not verified

Reported corrected, not verified.
Reported corrected, not verified.

Observation 2:
Observation 4:

Reported corrected, not verified.

Reported corrected, not verified.

DATES Ol'' INSPECTi'ON:

08!25/201 5(Tue), 08126/2015(Wed), 08/2712015(Thu), 08128/2015(Fri), 09/0 112015(The), 09/0212015(Wed), 09/03/2015(Thu),

09/0412015(Fri), 09/0912015(Wed), 09/ 1012015(Thu), 09/ ll/2015(Fri), 09/16/2015(Wed)

El.IPO..OYEE(S) SIGNAlURE

SEE REVERSE
OFTfoUSPAGE
FORM D A 483 (".QI)

Seema S. Singh, Investigator

Ian A. Pilc her, Investigator
PREVIOOSI!DTnONOBSOI.EIE

09/16/2015

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