673112
Ecometics, Inc. — FEI 1250013
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 22, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- 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 |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 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 |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1728 | 21 CFR 211.87 | Retest of approved components/containers/closures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |