FDA Inspection 616309 — Emilia Resources, LLC
The FDA completed an inspection of Emilia Resources, LLC on September 23, 2009 in De Kalb, MS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 23, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- De Kalb, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |