FDA Inspection 1327746 — Fiberoptics Technology, Inc.
The FDA completed an inspection of Fiberoptics Technology, Inc. on Jul 24, 2026 in Pomfret, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pomfret, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23137 | ISO 13485:2016 Clause 7.3.10 | Design and development file does not include or reference required records |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23231 | ISO 13485:2016 Clause 8.2.6 | Evidence of conformity to the acceptance criteria not maintained |
| 23267 | 21 CFR 820.35(c) | UDI was not recorded for each medical device or batch |