713517
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 25, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Clearfield, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4341 | 21 CFR 211.142(a) | Quarantine - written procedures |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |