807180
A.I.G Technologies Inc. — FEI 3003511617
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 20, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Deerfield Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 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 |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4313 | 21 CFR 211.84(c)(6) | Containers Marked to Show Samples Taken |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |