FDA Inspection
Xin Hua International Biological, LLCXin Hua International Biological, LLC – FDA Inspection, Dec 5, 2014
Record Details
This FDA Inspection record concerns Xin Hua International Biological, LLC, with an inspection on December 5, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 5, 2014
- Product Type
- Drugs
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ID · 53bbde82-4d68-4eb2-92b6-b643925ae01c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 906378
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
6- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.55Production, process controls - implement
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.127(d)Quality control operations - packaged, labeled; specifications
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
- 21 CFR 111.113(b)(2)Quality control - reject; specification not met
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Other FDA inspections of Xin Hua International Biological, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 26, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 17, 2013 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 4, 2012 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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