Drug factory · FDA FEI 3008756210
First Community Care, LLC
3024 James Savage Road, Midland, MI, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 27, 2012.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2012: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | First Community Care | 63121-123 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 27, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 27, 2012 inspection
- 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.
Registered with FDA for: manufacture.