FDA inspection

Acme Monaco Asia Pte. Ltd.: FDA inspection ending Sep 20, 2018

FDA inspection 1068528 · No Action Indicated (NAI) · Singapore

Key facts

Inspection ID	1068528
Firm	Acme Monaco Asia Pte. Ltd.
FEI number	3007064586
Address	1 Genting Link, Perfect One; Floor 04 Unit 05 06
City	Singapore
Fiscal year	2018
Inspection end date	Sep 20, 2018
Classification	No Action Indicated (NAI)
Project area	Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices
Product type	Devices

At a glance

None Citations
1–9 Posted citations
No Warning letter followed
Yes Form FDA 483 issued
No 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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