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FDA Inspection
•Clearlab SG Pte. Ltd.•November 17, 2023

Clearlab SG Pte. Ltd. – FDA Inspection, Nov 17, 2023

Record Details

This FDA Inspection record concerns Clearlab SG Pte. Ltd., with an inspection on November 17, 2023, issued by the Office of Inspections and Investigations.

Company
Clearlab SG Pte. Ltd.
Inspection Date
November 17, 2023
Office
Office of Inspections and Investigations
Person
  • Colin E. Tack (Issuing Officer)
View Company Profile

ID · f7dd2c65-3577-415e-bb36-11ad375608cb

Inspection Facts

Inspection number
1222954
FDA center
Medical Devices & Rad Health
Outcome
Form 483 issued

FDA Citations

5
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
  3. 21 CFR 820.250(b)Sampling plans
  4. 21 CFR 820.75(a)Documentation
  5. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Clearlab SG Pte. Ltd.

1
DateClassificationOfficeProject area
June 8, 2017Not classifiedOffice of Inspections and InvestigationsCompliance: Devices
Other documents for Clearlab SG Pte. Ltd.
  • FDA Inspection 1013282 - 2017-06-08

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