FDA Inspection
RR Donnelley - Supply Chain SolutionsRR Donnelley - Supply Chain Solutions – FDA Inspection, Sep 29, 2023
Record Details
This FDA Inspection record concerns RR Donnelley - Supply Chain Solutions, with an inspection on September 29, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e321e1cf-2b95-42e2-94a6-5a61cfd305ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1219058
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of RR Donnelley - Supply Chain Solutions
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 16, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for RR Donnelley - Supply Chain Solutions
- FDA Inspection 895543 - 2014-09-10
- FDA Inspection 753954 - 2011-11-16
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