FDA Inspection 714304 — Schwabe North America, Inc.
The FDA completed an inspection of Schwabe North America, Inc. on March 22, 2011 in Lehi, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lehi, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |