Drug factory · FDA FEI 3011630647
Sterling-Knight Pharmaceuticals, LLC
Ripley, Mississippi, 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 11, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2015: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Vexasyn | Tests it and labels it | Sterling Knight Pharmaceuticals,LLC | 69336-831 |
| 12-Hydroxyeicosapentaenoic Acid, (12r)- and 4,7,10,13,16,19-Docosahexaenoic Acid, (4e,7e,10e,13e,16e,19e)- and Omega-3 Fatty Acids | Makes it | Sterling Knight Pharmaceuticals,LLC | 69336-349 |
| Cholecalciferol and Folic Acid | Makes it and labels it | Sterling Knight Pharmaceuticals,LLC | 69336-330 |
| Diclofenac | Makes it, tests it and labels it | Sterling Knight Pharmaceuticals,LLC | 69336-827 |
| Lidocaine and Prilocaine | Makes it and labels it | Sterling Knight Pharmaceuticals,LLC | 69336-828 |
| Prenara | Makes it and labels it | Sterling Knight Pharmaceuticals,LLC | 69336-352 |
| Urea | Makes it and labels it | Sterling Knight Pharmaceuticals,LLC | 69336-810 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 11, 2019 | Problems found, fixed voluntarily | Unapproved and Misbranded Drugs | 4 |
| Apr 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 17, 2015 | No problems found | Unapproved and Misbranded Drugs | — |
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 11, 2019 inspection
- Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. - Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. - Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit. - Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit.