Drug factory · FDA FEI 3004620701
QPharma AB
Agneslundsvagen 27, Malmo, Sweden
Problems found, fixed voluntarily at FDA's last inspection, May 12, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2014: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ethinyl Estradiol and Segesterone | Makes it, tests it and packages it | Mayne Pharma Inc. | 68308-752 |
| Progesterone | Makes it | Caraco Pharmaceutical Laboratories, Ltd. | 70095-136 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 12, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 31, 2023 | No problems found | Drug Quality Assurance | — |
| Nov 23, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 1, 2016 | No problems found | Drug Quality Assurance | — |
| Mar 27, 2014 | 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.
Mar 27, 2014 inspection
- Actual vs. theoretical yields not determined 21 CFR 211.103
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing of the drug product.
Registered with FDA for: analysis; label; manufacture; pack.