FDA Inspection
Hemarus, LLCHemarus, LLC – FDA Inspection, Mar 2, 2012
Record Details
This FDA Inspection record concerns Hemarus, LLC, with an inspection on March 2, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Hemarus, LLC
- Inspection Date
- March 2, 2012
- Product Type
- Biologics
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ID · f6ec9246-7418-4142-85b3-8ae1ec8fc978
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 771123
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
15- 21 CFR 606.160(e)(1)Donor deferral record - each location
- 21 CFR 640.65(b)(8)Timing
- 21 CFR 640.76(c)Source Plasma - Re-labeling
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 640.72(b)Cross reference of donor record to unit of plasma
- 21 CFR 640.65(b)(1)(i)Serological test
- 21 CFR 640.63(a)Determining donor suitability
- 21 CFR 640.65(b)(2)(i)Physician review of results
- 21 CFR 606.160(b)Required records
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Other FDA inspections of Hemarus, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2020 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 5, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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