FDA Inspection
ITI Manufacturing, Inc.ITI Manufacturing, Inc. – FDA Inspection, Jun 3, 2026
Record Details
This FDA Inspection record concerns ITI Manufacturing, Inc., with an inspection on June 3, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1f150f2e-a4c4-4cb3-ab84-6b950b2a0012
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1320202
- Project area
- Compliance: Devices
FDA Citations
4- ISO 13485:2016 Clause 4.1.5External party controls do not include written quality agreements
- ISO 13485:2016 Clause 8.2.4Internal audit procedures not documented
- ISO 13485:2016 Clause 8.5.1Records of nonconforming product and actions taken not maintained
- ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ITI Manufacturing, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ITI Manufacturing, Inc.
- FDA Inspection 1182234 - 2022-10-28
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