FDA Inspection 1195194 — EPM Packaging, Inc.
The FDA completed an inspection of EPM Packaging, Inc. on Jan 12, 2023 in Lexington, NE. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 12, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lexington, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 2017 | 21 CFR 211.188(b)(5) | In-Process and Laboratory Control Results |