September 22, Yamamoto and another field inspector from CMS’s San
Francisco regional office named Sarah Bennett arrived at the Newark
facility and explained that they were there to survey the lab. Men in
dark suits wearing earpieces denied them entry and told them to wait
in a small reception room.
After a while, Sunny Balwani, Daniel Young, Heather King, and
Boies Schiller’s Meredith Dearborn arrived. They took the two CMS
inspectors to a conference room and insisted on giving them a
PowerPoint presentation. Although it felt like a diversion tactic,
Yamamoto and Bennett politely sat through it. As soon as it was over,
they asked for a tour of the lab.
As they headed out of the conference room, they were escorted by
more men in dark suits with fingers pressed to their ears. King and
Dearborn followed close behind, holding laptops and taking notes.
When they got to the lab rooms, they noticed that their doors were
equipped with fingerprint scanners and that there was a buzzing
sound when you entered. It reminded Yamamoto of the door buzzers
in liquor stores.
Yamamoto and Bennett had initially set aside two days for the
inspection, but they found so many problems and Theranos was
missing so much basic lab documentation that they concluded they
would have to return. Balwani asked for a two-month reprieve. He
claimed that the company’s new fiscal year was about to start and that
it was in the midst of raising new funding. They agreed to come back
in mid-November.
When they returned, the Journal investigation had been published,
ratcheting up pressure on the agency to take action. Yamamoto
noticed that security was a bit lighter and that Holmes was there to
greet them. Balwani and King were also present again, along with a
different set of outside attorneys and some lab consultants. The
inspectors split up: Yamamoto roamed through the lab rooms and
peppered the lab’s personnel with questions, followed everywhere he
went by Balwani, while Bennett set up shop in a conference room
where King and the other lawyers kept close tabs on her.
This time, they stayed four days. At one point, Bennett asked to