FDA Inspection 778480 — Emerald 3 Enterprises, Inc.
The FDA completed an inspection of Emerald 3 Enterprises, Inc. on Apr 20, 2012 in Camdenton, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 20, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Camdenton, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1449 | 21 CFR 211.111 | Deviations of production time limits |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |