Drug factory · FDA FEI 1122643
Bay View Homecare, Inc.
4404 Fitch Ave, Baltimore, MD, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 3, 2013.
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 2013: 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 | Bay View Homecare, Inc | 57999-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 3, 2013 | 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.
Jul 3, 2013 inspection
- Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - 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.
Registered with FDA for: manufacture.