582359
Sharp Clinical Services, LLC — FEI 3003673570
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bethlehem, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |