FDA Inspection 998560 — Magno-Humphries Inc.
The FDA completed an inspection of Magno-Humphries Inc. on Dec 19, 2016 in Tigard, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 19, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tigard, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |