Drug factory · FDA FEI 3002940723
Med-Air Transfill
4503 HUNTER ROAD, San Marcos, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 29, 2009.
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 2009: 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 | Rotech Healthcare Inc | 57439-000, 57439-001, 57439-005 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 29, 2009 | 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.
Dec 29, 2009 inspection
- Distinctive ID or code not recorded in batch record 21 CFR 211.105(b)
The batch records do not record the distinctive identification number to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
Registered with FDA for: manufacture; transfill.