FDA Inspection
Freeland Systems, LlcFreeland Systems, Llc – FDA Inspection, Jul 17, 2026
Record Details
This FDA Inspection record concerns Freeland Systems, Llc, with an inspection on July 17, 2026, issued by the Detroit District Office, covering medical devices & rad health.
- Office
- Detroit District Office
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ID · 2ebc875a-719a-4d37-a014-a001c66b1ed3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1329598
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- ISO 13485:2016 Clause 4.2.3Medical device file not established and maintained
- ISO 13485:2016 Clause 4.2.5Procedures for control of records not documented
- ISO 13485:2016 Clause 5.6.1Management review procedures not documented
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 8.2.4Internal audit procedures not documented
- ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented
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Other FDA inspections of Freeland Systems, Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Freeland Systems, Llc
- FDA Inspection 854121 - 2013-11-04
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