1. Walgreens Scrutinizes Theranos Testing
Drugstore chain won’t open new Theranos blood-testing centers while it seeks answers about startup’s technology, official says
[url=http://www.wsj.com/articles/walgreens-scrutinizes-theranos-testing-1445644015]http://www.wsj.com/articles/walgreens-scrutinizes-theranos-testing-1445644015[/url]
Walgreens Boots Alliance Inc. won’t open any new Theranos Inc. blood-testing centers until the startup company resolves questions about its technology, according to a Walgreens official.
On Thursday(Oct-22), a team from the drugstore chain met with senior Theranos executives, including founder and Chief Executive Elizabeth Holmes, at the startup’s headquarters in Palo Alto, Calif.
The meeting was requested by Walgreens after its directors and officials learned from in last week’s article The Wall Street Journal that the proprietary lab instrument developed by Theranos as the anchor of its growth strategy handled just a small fraction of the tests sold to consumers at the end of 2014, according to people familiar with the matter.
These people said Walgreens officials also were concerned after finding out in a follow-up article in the Journal that Theranos had stopped collecting tiny vials of blood drawn from finger pricks for all but one of its more than 240 tests.
Walgreens officials also were unaware of the Food and Drug Administration’s surprise inspection of Theranos facilities in August and September, the people added.
2. 272楼提到女CEO在接受WSJ.D live采访的时候承认，FDA对他们公司有过两次突击检查。
3. FDA 刚刚公布了两封 Form 483 letter！！！
What is Form 483 letter?
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgement, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
[url=http://www.fda.gov/ICECI/Inspections/ucm256377.htm]http://www.fda.gov/ICECI/Inspections/ucm256377.htm[/url]
[url=https://en.wikipedia.org/wiki/Form_FDA_483]https://en.wikipedia.org/wiki/Form_FDA_483[/url]
好了，Theranos收到的两封Form 483信里面提到的violation包括：
a)Devices for which listing is required have not been listed. （用了一些仪器，但是没有在给FDA提交的清单上）
b) Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
c) Complaints involving the possible failure of a device to meet any of its specifications were not reviewed. evaluated, and investigated where necessary.
d) Corrective and preventive action activities and/or results have not been documented (修正数据的行为未被记录下来）
e) Software validation activities and results for computers or automated data processing systems used as part of production and the quality system have not been documented. (同d)
f) Quality audits have not been performed
g) Design validation did not ensure the device conforms to defined user needs and intended uses.
h) Design input requirements were not adequately documented.
i) The design was not validated under actual or simulated use conditions.
j) Design input requirements were not adequately documented.
两封Form 483 信原件
[url=http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm469395.pdf]http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm469395.pdf[/url]
[url=http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm469396.pdf]http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm469396.pdf[/url]
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