FDA Inspection 765520 — Scribe Manufacturing, Inc.
The FDA completed an inspection of Scribe Manufacturing, Inc. on Jan 26, 2012 in Red Wing, MN. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 26, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Red Wing, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4336 | 21 CFR 211.150 | Written distribution procedure |