FDA Inspection 644311 — EPM Packaging, Inc.
The FDA completed an inspection of EPM Packaging, Inc. on February 4, 2010 in Lexington, NE. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lexington, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4576 | 21 CFR 211.192 | No written record of investigation |