FDA Inspection
Modal Manufacturing, LLCModal Manufacturing, LLC – FDA Inspection, Feb 15, 2017
Record Details
This FDA Inspection record concerns Modal Manufacturing, LLC, with an inspection on February 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e53b6554-1c44-4d94-95af-2c04fef9e26b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1003096
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.22Quality audits - 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 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Modal Manufacturing, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 8, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Modal Manufacturing, LLC
- FDA Inspection 1034573 - 2017-12-08
- FDA Inspection 1026893 - 2017-08-08
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