Drug factory · FDA FEI 3003368324
United Therapeutics Corporation
1040 Spring Street, Silver Spring, MD, United States
Problems found, fixed voluntarily at FDA's last inspection, May 2, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2008: 3 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Treprostinil | Makes it, makes the active ingredient, tests it and labels it | United Therapeutics Corporation | 66302-206, 66302-600, 66302-610 +17 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 2, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Mar 31, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jul 11, 2014 | No problems found | Drug Quality Assurance | — |
| May 29, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 12, 2011 | No problems found | Bioresearch Monitoring | — |
| Jun 28, 2011 | No problems found | Drug Quality Assurance | — |
| Feb 11, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 7, 2008 | 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.
May 2, 2024 inspection
- 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 written and followed. - 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. - Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
Mar 31, 2017 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy 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. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; api manufacture; label; manufacture.