FDA inspection

Prometheus Bio Inc.: FDA inspection ending Mar 3, 2017

FDA inspection 1009129 · Official Action Indicated (OAI) · Hangzhou

Key facts

Inspection ID	1009129
Firm	Prometheus Bio Inc.
FEI number	3011559327
Address	No. 17, 14 Street, Hangzhou Economic And Technological Development Zone
City	Hangzhou
Fiscal year	2017
Inspection end date	Mar 3, 2017
Classification	Official Action Indicated (OAI)
Project area	Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Bioresearch Monitoring\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices
Product type	Biologics, Devices, Drugs

At a glance

None Citations
1–9 Posted citations
No Warning letter followed
Yes Form FDA 483 issued
Yes Establishment inspection report (EIR) exists
1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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