FDA Inspection
MBi Distributing Inc.MBi Distributing Inc. – FDA Inspection, Jan 12, 2018
Record Details
This FDA Inspection record concerns MBi Distributing Inc., with an inspection on January 12, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d3660865-4b28-4b32-9b62-bcecf27d2c23
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1037569
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.184(c)Individual inventory record
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.184(b)Component Test Records
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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