FDA Inspection
Grimm Scientific IndustriesGrimm Scientific Industries – FDA Inspection, Sep 18, 2026
Record Details
This FDA Inspection record concerns Grimm Scientific Industries, with an inspection on September 18, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
- Company
- Grimm Scientific Industries
- Inspection Date
- September 18, 2026
- Product Type
- Medical Devices & Rad Health
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ID · ee6ff14b-59d5-4472-82e2-1f2509cfd1bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1336538
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Grimm Scientific Industries
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 13, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 29, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 2, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Grimm Scientific Industries
- FDA Inspection 1208256 - 2023-06-16
- FDA Inspection 1000600 - 2017-01-13
- FDA Inspection 850525 - 2013-08-29
- FDA Inspection 771780 - 2012-03-02
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