Drug factory · FDA FEI 1000151022
Norco, Inc.
63024 Sherman Rd., Bend, OR, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 18, 2015.
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 2015: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Transfills it | Norco, Inc. | 42602-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 18, 2015 | 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.
Mar 18, 2015 inspection
- Reporting of adverse drug experience to FDA 21 CFR 211.198(a)
Written procedures describing the handling of all written and oral complaints do not include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration.
Registered with FDA for: transfill.