FDA Inspection
United Health Products, Inc.United Health Products, Inc. – FDA Inspection, Oct 4, 2024
Record Details
This FDA Inspection record concerns United Health Products, Inc., with an inspection on October 4, 2024, issued by the New Jersey District Office, covering medical devices & rad health.
- Company
- United Health Products, Inc.
- Inspection Date
- October 4, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · af546d5b-847b-46d2-8095-2e4fda7baa76
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1250925
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
FDA Citations
7- 21 CFR 812.46(b)(1)No evaluation of unanticipated adverse effects
- 21 CFR 812.140(b)(6)Other sponsor records required by FDA inadequate
- 21 CFR 812.140(b)(2)Sponsor device disposition records inadequate
- 21 CFR 812.7(a)Promotion or test marketing
- 21 CFR 812.40Sponsors' general responsibilities
- 21 CFR 812.2(b)Abbreviated requirements / non-significant risk study
- 21 CFR 812.5(a)Label does not contain required information
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