Drug factory · FDA FEI 3001452037
Rotech
4201 YALE BLVD. N.E. SUITE E, Albuquerque, NM, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 13, 2012.
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 2012: 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 |
|---|---|---|---|
| Sep 13, 2012 | 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.
Sep 13, 2012 inspection
- Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals . - Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Registered with FDA for: manufacture; transfill.