Drug factory · FDA FEI 2127270
Oxygen Service Co., Inc.
1002 INDUSTRIAL DR S, Sauk Rapids, MN, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 24, 2013.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2010: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Oxygen Service Company, Inc | 49696-100 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 24, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 22, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 24, 2013 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments and apparatus is not done at suitable intervals in accordance with an established written program. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
Jan 22, 2010 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments and gauges is not done at suitable intervals in accordance with an established written program. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: manufacture.