FDA Inspection
ASI Marketing Group, LLCASI Marketing Group, LLC – FDA Inspection, Sep 11, 2009
Record Details
This FDA Inspection record concerns ASI Marketing Group, LLC, with an inspection on September 11, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ASI Marketing Group, LLC
- Inspection Date
- September 11, 2009
- Product Type
- Drugs
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ID · ed5ee528-ad80-4f82-a977-3c603e1c826c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611743
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.103Yield calculations not verified by 2nd person
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Other FDA inspections of ASI Marketing Group, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
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