FDA Inspection 715435 — Magno-Humphries Inc.
The FDA completed an inspection of Magno-Humphries Inc. on March 10, 2011 in Tigard, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tigard, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1506 | 21 CFR 211.122(e) | Destruction of obsolete labeling |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4343 | 21 CFR 211.160(b)(1) | Incoming lots - conformance to written specs- |
| 4346 | 21 CFR 211.160(b)(1) | Retesting when subject to deterioration |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 7376 | 21 CFR 56.109(e) | IRB disapprovals not involving IC exception |