FDA Inspection
Specialty Manufacturing, Inc.Specialty Manufacturing, Inc. – FDA Inspection, Oct 25, 2018
Record Details
This FDA Inspection record concerns Specialty Manufacturing, Inc., with an inspection on October 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e32db3fb-6dc9-43e3-8103-2134f33e509f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1069926
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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