Prometheus Bio Inc.

Form 483 issued March 3, 2017 · Hangzhou, China

Inspection
Feb 13 – Mar 3, 2017
Observations
1
Pages
3
FEI number
3011559327

In short: On March 3, 2017, FDA issued a Form 483 with 1 observation to Prometheus Bio Inc. in Hangzhou, China (FEI 3011559327) after an inspection that ran Feb 13 – Mar 3, 2017. The investigators were Felix J. Marrero and Marijo B. Kambere. Most observations concern gLP.

At a glance

1 of 1 observations on this 483 concern glp.

GLP1

What FDA observed

Preview: the opening words of each observation
  1. 01

    The authenticity of source data used to support{&)@frecords…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

Questions about this 483

What did FDA find at Prometheus Bio Inc.?

FDA listed 1 observation on this Form 483, mostly about gLP. The opening words of each observation are shown on this page.

Who inspected Prometheus Bio Inc.?

Felix J. Marrero and Marijo B. Kambere are named on this Form 483, for the inspection of Feb 13 – Mar 3, 2017. Each investigator has a profile showing what they cite most.

When was Prometheus Bio Inc. inspected by FDA?

The inspection ran Feb 13 – Mar 3, 2017, and the Form 483 is dated March 3, 2017.

How do I get the full Form 483 for Prometheus Bio Inc.?

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