Drug factory · FDA FEI 1000512366
Lincare Inc.
5522 Harford Rd., Baltimore, MD, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 9, 2013.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2009: 2 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 9, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jul 22, 2010 | No problems found | Drug Quality Assurance | — |
| Oct 5, 2009 | No problems found | Drug Quality Assurance | — |
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 9, 2013 inspection
- Written complaint record to be maintained at facility 21 CFR 211.198(b)
A written record of each complaint is not maintained in a file designated for drug product complaints at the facility where the drug product was manufactured, processed or packed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing of a drug product lack the training required to perform their assigned functions. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: transfill.