Drug factory · FDA FEI 3003206799
Oxygen Plus, Inc. dba Summit Respiratory
6950 W Jefferson Ave Ste 270, Lakewood, CO, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 14, 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 | Rotech Healthcare Inc | 57439-001, 57439-005 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 14, 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.
Oct 14, 2010 inspection
- 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 independently checked, dated, and signed by a second person. - Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not followed. - 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 and fully followed.
Registered with FDA for: manufacture; transfill.