FDA Inspection
Robbins Instruments, LLCRobbins Instruments, LLC – FDA Inspection, Jan 27, 2026
Record Details
This FDA Inspection record concerns Robbins Instruments, LLC, with an inspection on January 27, 2026, issued by the Dallas District Office, covering medical devices & rad health.
- Company
- Robbins Instruments, LLC
- Inspection Date
- January 27, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · dd4df276-5bfb-4efe-819f-5170780e84aa
Inspection Facts
- Inspection number
- 1300058
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.120(b)Labeling inspection - UDI
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.200(d)Service reports - UDI
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.80(e)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Robbins Instruments, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 22, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 15, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Robbins Instruments, LLC
- FDA Inspection 1239967 - 2024-05-31
- FDA Inspection 988646 - 2016-09-22
- FDA Inspection 842783 - 2013-07-15
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