Clearlab SG Pte. Ltd. – FDA Inspection, Jun 8, 2017

Record Details

This FDA Inspection record concerns Clearlab SG Pte. Ltd., with an inspection on June 8, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Clearlab SG Pte. Ltd.
Inspection Date: June 8, 2017
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Kelvin Cheung (Issuing Officer)

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ID · 572ce0fe-44f7-4b43-b550-12e18d487bd9

Inspection Facts

Inspection number: 1013282
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.30(e)Design review - documentation
21 CFR 820.30(f)Design verification - documentation
21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces

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Other FDA inspections of Clearlab SG Pte. Ltd.

Date	Classification	Office	Project area
November 17, 2023	Not classified	Office of Inspections and Investigations

Other documents for Clearlab SG Pte. Ltd.

FDA Inspection 1222954 - 2023-11-17

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Date

Classification

Office

Project area

November 17, 2023

Not classified

Office of Inspections and Investigations