FDA Inspection
Fiberoptic Technology, Inc.Fiberoptic Technology, Inc. – FDA Inspection, Jul 24, 2026
Record Details
This FDA Inspection record concerns Fiberoptic Technology, Inc., with an inspection on July 24, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b23ccf9d-96f3-4a32-85e0-7e213e5b5998
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1327746
- Project area
- Compliance: Devices
FDA Citations
8- ISO 13485:2016 Clause 4.1.6Evidence of conformity to the acceptance criteria not maintained
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.1Criteria for the evaluation and selection of suppliers not established
- 21 CFR 820.35(c)UDI was not recorded for each medical device or batch
- ISO 13485:2016 Clause 7.3.10Design and development file does not include or reference required records
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 8.2.6Evidence of conformity to the acceptance criteria not maintained
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Other FDA inspections of Fiberoptic Technology, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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