Drug factory · FDA FEI 3009518416
Ascent Pharmaceuticals Inc
400 S Technology Dr, Central Islip, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 9, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
18 drug inspections on record since 2012: 3 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 9, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 9, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 15, 2022 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Sep 15, 2022 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Oct 13, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 13, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 7, 2018 | No problems found | Bioresearch Monitoring | — |
| Nov 7, 2018 | No problems found | Bioresearch Monitoring | — |
| Jul 27, 2018 | No problems found | Bioresearch Monitoring | — |
| Jul 27, 2018 | No problems found | Bioresearch Monitoring | — |
| Feb 21, 2018 | No problems found | Drug Quality Assurance | — |
| Feb 21, 2018 | No problems found | Drug Quality Assurance | — |
| Nov 9, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 9, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 26, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 26, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Dec 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 15, 2022 inspection
- Failure to comply with REMS Implementation System FDCA 505-1(f)(4)
An application holder did not maintain a Support / Call Center or a REMS Program website, as required by your approved REMS Implementation System. - Failure to comply with REMS Implementation System FDCA 505-1(f)(4)
An application holder did not maintain a Support / Call Center or a REMS Program website, as required by your approved REMS Implementation System.
Dec 6, 2012 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not followed. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not followed. - Samples (various types) representative, identified properly 21 CFR 211.160(b)(1)
Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of components and drug product containers are not adequately identified. - Samples (various types) representative, identified properly 21 CFR 211.160(b)(1)
Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of components and drug product containers are not adequately identified. - Washing and toilet facilities are deficient 21 CFR 211.52
Washing and toilet facilities lack hot and cold water and soap or detergent. - Washing and toilet facilities are deficient 21 CFR 211.52
Washing and toilet facilities lack hot and cold water and soap or detergent.
Registered with FDA for: analysis; label; manufacture; pack.