FDA Inspection 1272618 — EPM Packaging, Inc.
The FDA completed an inspection of EPM Packaging, Inc. on June 13, 2025 in Lexington, NE. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 13, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lexington, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |