FDA Inspection
Onanon IncOnanon Inc – FDA Inspection, Apr 21, 2026
Record Details
This FDA Inspection record concerns Onanon Inc, with an inspection on April 21, 2026, issued by the Center for Devices and Radiological Health.
- Company
- Onanon Inc
- Inspection Date
- April 21, 2026
View Company Profile
ID · 55fa1e43-733b-4512-92c0-2010b7b9aa71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1314866
- Project area
- Compliance: Devices
FDA Citations
7- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- 21 CFR 803Lack of Written MDR Procedures
- ISO 13485:2016 Clause 7.1Supplier monitoring and re-evaluation not planned
- ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained
- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 7.4.1Supplier monitoring and re-evaluation not planned
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