Drug factory · FDA FEI 3003750771
Founders Healthcare LLC, DBA Preferred Homecare
6900 W. Jefferson Ave., Ste 125, Lakewood, CO, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 30, 2009.
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 2009: 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, repackages it and transfills it | Founders Healthcare LLC, dba Preferred Homecare, Lincare Inc. | 64346-001, 57800-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 30, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 30, 2009 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. - Supervisor Training/Education/Experience 21 CFR 211.25(b)
Individuals responsible for supervising the processing of a drug product lack the education and training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
Registered with FDA for: repack; transfill.