Drug factory · FDA FEI 1000220651
Premier Medical Corporation
Denver, Colorado, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Apr 26, 2012.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2012: 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 | Premier Medical Corporation | 61604-9068 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 26, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Apr 26, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Apr 26, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Apr 26, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 26, 2012 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. - 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. - 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. - 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.