Drug factory · FDA FEI 1946929
Curium US LLC
2703 Wagner Place, Maryland Heights, MO, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 18, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2010: 4 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Copper Oxodotreotide Cu-64 | Makes it, makes the active ingredient and tests it | Curium US LLC | 69945-064 |
| Oxidronic Acid | Makes it, makes the active ingredient and tests it | Curium US LLC | 69945-091 |
| Stannous Cation | Makes it and tests it | Curium US LLC | 69945-068 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 18, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 13, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 18, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 27, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 27, 2013 | No problems found | Bioresearch Monitoring | — |
| Mar 27, 2013 | No problems found | Bioresearch Monitoring | — |
| Aug 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| May 25, 2011 | No problems found | Drug Quality Assurance | — |
| May 23, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 26, 2010 | 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.
Aug 6, 2012 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Certificates of Testing (Containers, Closures) 21 CFR 211.84(d)(3)
Certificates of testing of are accepted in lieu of testing without establishing the reliability of the supplier's test results through appropriate validation of the test results at appropriate intervals. - Quality System Procedures 21 CFR 820.20(e)
Quality system procedures and instructions have not been established. - Calibration, Inspection, etc. Procedures Lack of or Inadequ 21 CFR 820.72(a)
Procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained have not been adequately established.
Registered with FDA for: analysis; api manufacture; manufacture; positron emission tomography drug production.