FDA Inspection
BOULDER BIOMED DBA BOULDER IQBOULDER BIOMED DBA BOULDER IQ – FDA Inspection, Oct 30, 2023
Record Details
This FDA Inspection record concerns BOULDER BIOMED DBA BOULDER IQ, with an inspection on October 30, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3c241418-4c1a-4584-9800-ae6472ca9df9
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1221441
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.70(a)Process control procedures, 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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