Drug factory · FDA FEI 3003749112
Ipsen Pharma Biotech
PARC D'ACTIVITE DE SIGNES CHE DEPARTEMENTAL 402, Signes, France
Problems found, fixed voluntarily at FDA's last inspection, Mar 29, 2024.
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: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Irinotecan | Makes it, tests it, packages it and labels it | Ipsen Biopharmaceuticals, Inc. | 15054-0043 |
| Lanreotide | Makes it | Ipsen Biopharmaceuticals, Inc. | 15054-1060, 15054-1090, 15054-1120 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 29, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 6, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 11, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 12, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 24, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 12, 2016 inspection
- 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. - Air Supply 21 CFR 211.42(c)(10)(iii)
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. - 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.
Jun 24, 2014 inspection
- Failing drug products not rejected 21 CFR 211.165(f)
Drug products failing to meet established standards, specifications, and quality control criteria are not rejected. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - 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.
Registered with FDA for: analysis; label; manufacture; pack.