FDA Inspection
Magnesium Direct IncMagnesium Direct Inc – FDA Inspection, Sep 21, 2018
Record Details
This FDA Inspection record concerns Magnesium Direct Inc, with an inspection on September 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 11b3ab67-1ee7-4e72-b7d7-7329781df430
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066524
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Magnesium Direct Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2017 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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