FDA Inspection
Mallinckrodt Manufacturing LLCMallinckrodt Manufacturing LLC – FDA Inspection, Aug 17, 2010
Record Details
This FDA Inspection record concerns Mallinckrodt Manufacturing LLC, with an inspection on August 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 17, 2010
- Product Type
- Devices
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ID · bfc3fb31-4622-4b17-839f-7eb0a684eb91
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 676845
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Mallinckrodt Manufacturing LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mallinckrodt Manufacturing LLC
- FDA Inspection 919255 - 2015-03-13
- FDA Inspection 752094 - 2011-10-21
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