FDA Inspection
Magnesium Direct IncMagnesium Direct Inc – FDA Inspection, Feb 3, 2017
Record Details
This FDA Inspection record concerns Magnesium Direct Inc, with an inspection on February 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Ivy E. Sweeney (Issuing Officer)
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ID · 5ceadca9-c4ae-4649-bce2-31edc42e660d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1001563
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Magnesium Direct Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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