FDA Inspection 1013173 — Helget Gas Products, Inc.
The FDA completed an inspection of Helget Gas Products, Inc. on Jun 7, 2017 in Omaha, 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
- Jun 7, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Omaha, NE (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |