FDA Inspection 858927 — Emilia Resources, LLC
The FDA completed an inspection of Emilia Resources, LLC on December 6, 2013 in De Kalb, MS. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 6, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- De Kalb, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |