Drug factory · FDA FEI 1937898
GenVentures, Inc dba MercyOne Genesis Kimberly Road Home Medical Equipment
1803 East Kimberly Road, Davenport, IA, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 8, 2010.
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 2010: 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 | GenVentures, Inc dba MercyOne Genesis Kimberly Road Home Medical Equipment | 72995-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 8, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 8, 2010 inspection
- Actual vs. theoretical yields not determined 21 CFR 211.103
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of processing of the drug product. - Sampling/testing of labeling/packaging materials 21 CFR 211.122(a)
Labeling and packaging materials are not examined upon receipt and before use in packaging and labeling of a drug product. - Signature and checking of records -- 2 persons 21 CFR 211.186(a)
The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person.
Registered with FDA for: manufacture.