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Profissional Documentos
Cultura Documentos
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
"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
A.
inte:nd~:d to be
device to collect patient samples and have reported the results with at
OBSERVATION 4
SEE REVERSE
OF THIS PAGE
FORM
~~
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...
design
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
09/16/2015
08/25/2015 - 09/16/2015*
FEINUM!IER
TO:
I STREET""'-""""
ARIINAME
Theranos , Inc.
' Palo Al t o, CA
94304-1111
Manufacturer
Observation Annotations
Observation 1:
Observation 3:
Observation 5:
Observation 2:
Observation 4:
El.IPO..OYEE(S) SIGNAlURE
SEE REVERSE
OFTfoUSPAGE
FORM D A 483 (".QI)
09/16/2015
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