FDA Inspection
Modal Manufacturing, LLCModal Manufacturing, LLC – FDA Inspection, Dec 8, 2017
Record Details
This FDA Inspection record concerns Modal Manufacturing, LLC, with an inspection on December 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e219ec37-f6fe-48f2-b787-44040117a8bc
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1034573
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Modal Manufacturing, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 15, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Modal Manufacturing, LLC
- FDA Inspection 1026893 - 2017-08-08
- FDA Inspection 1003096 - 2017-02-15
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