FDA Inspection
Bioteque America, IncBioteque America, Inc – FDA Inspection, Apr 23, 2025
Record Details
This FDA Inspection record concerns Bioteque America, Inc, with an inspection on April 23, 2025, issued by the Dallas District Office, covering medical devices & rad health.
- Office
- Dallas District Office
- Person
View Company Profile
ID · 69261441-ae1a-4f58-bc27-440a92fd3dd8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1271607
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 830.310(b)GUDID Information required for unique device identification.
- 21 CFR 803.17Lack of Written MDR Procedures
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