Drug factory · FDA FEI 1000346340
Ipsen Biopharm Ltd
Unit 9 Ash Road Wrexham Industrial Estate, Wrexham, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, May 22, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2010: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Botulinum Toxin Type A | Makes it | Galderma Laboratories, L.P., Ipsen Biopharmaceuticals, Inc. | 0299-5962, 15054-0500, 15054-0530 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 22, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 26, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 12, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jul 8, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 18, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 12, 2010 | No problems found | 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.
Sep 12, 2017 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not reviewed and approved by the quality control unit. - 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 established, written and followed. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. - 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. Electronic records are used, but they do not meet retention, system access limitation and systems documentation control requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Jul 8, 2014 inspection
- No written record of investigation 21 CFR 211.192
Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.