FDA Inspection
Precision Medical TechnologiesPrecision Medical Technologies – FDA Inspection, Sep 11, 2026
Record Details
This FDA Inspection record concerns Precision Medical Technologies, with an inspection on September 11, 2026, issued by the Detroit District Office, covering medical devices & rad health.
- Inspection Date
- September 11, 2026
- Product Type
- Medical Devices & Rad Health
- Office
- Detroit District Office
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ID · 19661523-d0f7-4eeb-b963-aa5a63def3cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1335526
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 7.5.1Medical device or batch records not adequate
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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