FDA Inspection
Tridens Biologics, LLC.Tridens Biologics, LLC. – FDA Inspection, Nov 16, 2015
Record Details
This FDA Inspection record concerns Tridens Biologics, LLC., with an inspection on November 16, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Tridens Biologics, LLC.
- Inspection Date
- November 16, 2015
- Product Type
- Biologics
View Company Profile
ID · 11dd710c-11f7-4af9-a215-2d6d3bbdf82c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971018
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.290(f)Timely informing of consignees
- 21 CFR 1271.180(d)Adopted from another organization
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.180(b)Review and approval-responsible person
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