827540
Ecometics, Inc. — FEI 1250013
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Norwalk, CT (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |