FDA Inspection
Spintech LLCSpintech LLC – FDA Inspection, Jun 8, 2022
Record Details
This FDA Inspection record concerns Spintech LLC, with an inspection on June 8, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spintech LLC
- Inspection Date
- June 8, 2022
- Product Type
- Devices
View Company Profile
ID · c648494e-839a-4a8a-ae87-9c8b03f04173
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1171436
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17Lack of Written MDR Procedures
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