Drug factory · FDA FEI 1527688
Bernens Convalescent Pharmacy, Inc
5053 Glenway Ave, Cincinnati, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 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 | Bernens Convalescent Pharmacy, Inc | 57957-0007 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 30, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
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 30, 2009 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not reviewed and approved by the quality control unit. - 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. - In-process materials characteristics testing 21 CFR 211.110(c)
In-process materials are not tested for identity and purity and approved or rejected by the quality control unit during the production process. - Prevention of cross contamination, mix-ups 21 CFR 211.130(a)
There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.