FDA Inspection 920218 — Deseret Laboratories, Inc.
The FDA completed an inspection of Deseret Laboratories, Inc. on March 27, 2015 in Saint George, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint George, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |