FDA Inspection
Rockford SpecialtiesRockford Specialties – FDA Inspection, Nov 12, 2013
Record Details
This FDA Inspection record concerns Rockford Specialties, with an inspection on November 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Rockford Specialties
- Inspection Date
- November 12, 2013
- Product Type
- Devices
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ID · 92ec183a-eac1-4746-accb-78298c13bf8a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 855042
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Rockford Specialties
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2026 | NAI | Chicago District Office | Postmarket Assurance: Devices |
| September 10, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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