Drug factory · FDA FEI 1000123074
Rotech Home Medical Care
4118 PLANTATION ROAD NE, Roanoke, VA, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 30, 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 |
|---|---|---|---|
| Mar 30, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 30, 2012 inspection
- Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, and specificity of test methods have not been established and documented. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - 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.