FDA Inspection 1037569 — MBi Distributing Inc.
The FDA completed an inspection of MBi Distributing Inc. on Jan 12, 2018 in Lindon, UT. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 12, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Lindon, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1928 | 21 CFR 211.166(c)(1) | Homeopathic drugs, assessment of stability |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2001 | 21 CFR 211.184(b) | Component Test Records |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |