FDA Inspection
Millstone Medical Outsourcing, LLCMillstone Medical Outsourcing, LLC – FDA Inspection, Dec 18, 2024
Record Details
This FDA Inspection record concerns Millstone Medical Outsourcing, LLC, with an inspection on December 18, 2024, issued by the New England District Office, covering medical devices & rad health.
- Inspection Date
- December 18, 2024
- Product Type
- Medical Devices & Rad Health
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ID · df6c0c95-4597-4a0c-abbc-84e6bc7168ff
Inspection Facts
- Inspection number
- 1254027
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Millstone Medical Outsourcing, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 10, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 14, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Millstone Medical Outsourcing, LLC
- FDA Inspection 1155225 - 2021-10-22
- FDA Inspection 858998 - 2013-12-10
- FDA Inspection 700234 - 2010-12-14
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