Drug factory · FDA FEI 1000160561
Stason Pharmaceuticals, Inc.
Irvine, California, United States
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, Apr 13, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
11 drug inspections on record since 2009: 3 with no problems, 7 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Anastrozole | Makes it | Stason Pharmaceuticals, Inc | 60763-376 |
| Cyproheptadine | Makes it | C.O. Truxton, Inc. | 0463-6080 |
| Mercaptopurine | Makes it | Florida Pharmaceutical Products, LLC. | 69076-913 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 13, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Oct 25, 2019 | Serious problems, FDA action | Drug Quality Assurance | — |
| Aug 24, 2018 | No problems found | Drug Quality Assurance | — |
| Mar 8, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 22, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 18, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 8, 2013 | No problems found | Drug Quality Assurance | — |
| Jul 12, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 18, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 24, 2010 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Dec 16, 2009 | 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.
Apr 13, 2021 inspection
- 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. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
Aug 24, 2010 inspection
- Interval 21 CFR 314.80(c)(2)
Periodic reports of non-alert adverse drug experiences have not been submitted quarterly for an application which was approved less than three years ago and yearly for an application which was approved three or more years ago.