Drug factory · FDA FEI 405
Vantive Manufacturing Limited
Moneen Road, Castlebar, Ireland
Problems found, fixed voluntarily at FDA's last inspection, Dec 12, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2014: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride and Dextro | Makes it, tests it, packages it, labels it and sterilizes it | Vantive US Healthcare LLC | 0941-0484, 0941-0487, 0941-0490 +5 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 12, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 6, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Oct 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 6, 2018 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. - Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Oct 14, 2014 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 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. - 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.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; sterilize.