FDA Inspection
Frontier Biologics LLCFrontier Biologics LLC – FDA Inspection, Mar 8, 2024
Record Details
This FDA Inspection record concerns Frontier Biologics LLC, with an inspection on March 8, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · b1590252-7cc5-4cd2-a51e-f1c2075c1a9b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1232206
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Enforcement
- Warning Letter
FDA Citations
14- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
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