Drug factory · FDA FEI 3006428348
Genesis Respiratory Services
600 West Emmitt Avenue, Waverly, OH, United States
No problems found at FDA's last inspection, Nov 27, 2012.
No Action Indicated: inspectors found no objectionable conditions.
1 drug inspection on record since 2012: 1 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Genesis Respiratory Services | 52481-2481 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 27, 2012 | No problems found | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 27, 2012 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Registered with FDA for: manufacture.