Drug factory · FDA FEI 3002931334
Larry's Home Oxygen, Inc.
115 S Grand St., Enid, OK, United States
No problems found at FDA's last inspection, Feb 24, 2016.
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 | Larry's Home Oxygen, Inc. | 65453-123 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 24, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 26, 2011 | Problems found, fixed voluntarily | 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.
Aug 26, 2011 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.