Drug factory · FDA FEI 1036301
Medox Corporation
5691 Derek Ave, Sarasota, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 20, 2011.
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 2011: 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 | Medox Corporation | 53683-0001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 20, 2011 | 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.
Jan 20, 2011 inspection
- Written procedures describing in detail 21 CFR 211.122(a)
There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, and handling of labeling and packaging materials. - 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 prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person. - 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.
Registered with FDA for: manufacture.