FDA Inspection
Racer Technology Pte LtdRacer Technology Pte Ltd – FDA Inspection, Jun 6, 2013
Record Details
This FDA Inspection record concerns Racer Technology Pte Ltd, with an inspection on June 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Racer Technology Pte Ltd
- Inspection Date
- June 6, 2013
- Product Type
- Devices
View Company Profile
ID · 984b1671-b69a-4727-8782-b8e71b3a0543
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 840299
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Racer Technology Pte Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2023 | Not classified | Office of Inspections and Investigations | |
| March 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 2, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Racer Technology Pte Ltd
- FDA Inspection 1198012 - 2023-02-22
- FDA Inspection 920190 - 2015-03-10
- FDA Inspection 649047 - 2010-02-02
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