FDA Inspection
Mallinckrodt Manufacturing LLCMallinckrodt Manufacturing LLC – FDA Inspection, Oct 21, 2011
Record Details
This FDA Inspection record concerns Mallinckrodt Manufacturing LLC, with an inspection on October 21, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 21, 2011
- Product Type
- Devices
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ID · 89dfe379-4965-4e55-98d4-8406b059b0f2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752094
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 806.20(b)(5)Records of communications
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
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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 |
| August 17, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mallinckrodt Manufacturing LLC
- FDA Inspection 919255 - 2015-03-13
- FDA Inspection 676845 - 2010-08-17
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