Drug factory · FDA FEI 1000150308
Lincare Inc.
1020 East Palmdale, Tucson, AZ, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 20, 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 | Lincare Inc. | 57800-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 20, 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.
Aug 20, 2015 inspection
- 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: transfill.