Drug factory · FDA FEI 3002806288
Kaysersberg Pharmaceuticals
23 avenue Georges Ferrenbach, Kaysersberg-Vignoble, France
Problems found, fixed voluntarily at FDA's last inspection, May 17, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2010: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dorzolamide and Timolol | Makes it, tests it, packages it and labels it | Ingenus Pharmaceuticals, LLC | 50742-323 |
| Tafluprost | Makes it, tests it, packages it and labels it | Ingenus Pharmaceuticals, LLC | 50742-339 |
| Timolol | Makes it, tests it, packages it and labels it | Ingenus Pharmaceuticals, LLC | 50742-287, 50742-288 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 17, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 1, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 19, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
| Apr 19, 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.
Jul 19, 2016 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance. - Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - 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 in-process materials conform to appropriate standards of identity, strength, quality and purity. - 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. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Written sanitation procedures lacking 21 CFR 211.56(b)
There is a lack of written procedures describing in sufficient detail the methods, equipment and materials to be used for sanitation. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and parameters relevant to the operation. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.