FDA Inspection
Americord Registry LLCAmericord Registry LLC – FDA Inspection, Nov 17, 2025
Record Details
This FDA Inspection record concerns Americord Registry LLC, with an inspection on November 17, 2025, issued by the New Jersey District Office, covering biologics.
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ID · 884dbde4-9ded-402c-83fd-6c47a5682af4
Inspection Facts
- Inspection number
- 1287808
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
17- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.250(a)Controlling the labeling of HCT/Ps
- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.60(a)Completion of eligibility determination
Showing 10 of 17 citations.
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Other FDA inspections of Americord Registry LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 13, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 5, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Americord Registry LLC
- FDA Inspection 1195208 - 2023-01-13
- FDA Inspection 873007 - 2014-03-05
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