FDA Inspection
Auxilium Medical Inc.Auxilium Medical Inc. – FDA Inspection, Mar 26, 2025
Record Details
This FDA Inspection record concerns Auxilium Medical Inc., with an inspection on March 26, 2025, issued by the Atlanta District Office, covering medical devices & rad health.
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ID · 01b0d4a6-7479-4854-8b70-31f16e931e46
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1264972
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
12- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.184DHR content
- 21 CFR 820.181(a)DMR device specifications
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