FDA Inspection
Manfacturing Technology and Services, LLCManfacturing Technology and Services, LLC – FDA Inspection, Jul 31, 2019
Record Details
This FDA Inspection record concerns Manfacturing Technology and Services, LLC, with an inspection on July 31, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Wendy R. Blame (Issuing Officer)
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ID · d3784817-3709-419e-a18d-9091e7ac2210
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098094
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Manfacturing Technology and Services, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2026 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Manfacturing Technology and Services, LLC
- FDA Inspection 1327524 - 2026-07-21
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