FDA Inspection 1157204 — Hiers Enterprises, LLC
The FDA completed an inspection of Hiers Enterprises, LLC on Nov 10, 2021 in Roseburg, OR. 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
- Nov 10, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Roseburg, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18937 | FDCA 501(a)(2)(A) | Beta-lactam drugs, inadequate sanitation |
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 18942 | FDCA 501(a)(2)(A) | Personnel habits, contamination |