Drug factory · FDA FEI 3003500482
GC Medical Equipment, Inc.
4655 State Road, Peninsula, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 18, 2016.
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 2016: 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 | GC Medical Equipment, Inc. | 66878-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 18, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 18, 2016 inspection
- Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records are not prepared for each batch of drug product produced. - Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness.
Registered with FDA for: manufacture.