FDA Inspection
ASI Marketing Group, LLCASI Marketing Group, LLC – FDA Inspection, Aug 31, 2018
Record Details
This FDA Inspection record concerns ASI Marketing Group, LLC, with an inspection on August 31, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 76b58fd3-7bf9-4b2b-b0ba-6d47a001a818
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1064324
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of ASI Marketing Group, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| November 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 22, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 11, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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