FDA Inspection
Biogenix USA, LLCBiogenix USA, LLC – FDA Inspection, Aug 5, 2013
Record Details
This FDA Inspection record concerns Biogenix USA, LLC, with an inspection on August 5, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Biogenix USA, LLC
- Inspection Date
- August 5, 2013
- Product Type
- Drugs
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ID · ee98ae75-5a4c-406d-b921-9bae629b1f46
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 844666
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
4- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.20(c)(3)Physical plant - separate areas for products
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