FDA Inspection 714300 — Wasatch Product Development, LLC
The FDA completed an inspection of Wasatch Product Development, LLC on March 11, 2011 in Draper, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 11, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Draper, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4576 | 21 CFR 211.192 | No written record of investigation |