FDA Inspection 987996 — Ecometics, Inc.
The FDA completed an inspection of Ecometics, Inc. on September 29, 2016 in Norwalk, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- 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 |
| 1409 | 21 CFR 211.42(c)(4) | In-Process Material Area |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |