Drug factory · FDA FEI 3009751549
Ultra Mix (Aust) Pty Ltd
West Footscray, Australia
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Sep 28, 2017.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2016: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Eucalyptus Oil and Tea Tree Oil | Makes it | Ultra Mix (Aust) Pty Ltd | 69594-004 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 28, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jun 24, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
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 28, 2017 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - 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 and fully followed.