FDA Inspection 640001 — Oxygen Service Co., Inc.
The FDA completed an inspection of Oxygen Service Co., Inc. on Jan 22, 2010 in Sauk Rapids, MN. 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 22, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sauk Rapids, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |