Drug factory · FDA FEI 1000139780
Northwest Respiratory Services
1243 Eagan Industrial Rd, Eagan, MN, United States
No problems found at FDA's last inspection, Nov 18, 2013.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2011: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Northwest Respiratory Services | 55703-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 18, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 14, 2011 | 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 14, 2011 inspection
- 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. - Recall facilitation 21 CFR 211.150(b)
A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity. - Complaint Record at Location of Investigation 21 CFR 211.198(b)(2)
Complaint records are deficient in that they are not maintained at the establishment where the investigation occurred.
Registered with FDA for: manufacture.