1151267
Ecometics, Inc. — FEI 1250013
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 10, 2021
- Fiscal Year
- 2021
- 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 |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4576 | 21 CFR 211.192 | No written record of investigation |