Drug factory · FDA FEI 3002806460

Vantive Manufacturing Pte. Ltd.

Singapore, Singapore

Matched to FDA's records by company name, because this plant's registration on the label has expired.

Serious problems, FDA action at FDA's last inspection, Dec 13, 2024.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

1 drug inspection on record since 2024: 0 with no problems, 0 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chlorid	Makes it, tests it, packages it, labels it and sterilizes it	Vantive US Healthcare LLC	0941-0707
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	0941-0705

Ended	Result	Program	Problems noted
Dec 13, 2024	Serious problems, FDA action	Drug Quality Assurance	3

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components, in-process materials and drug products 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.
Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the storage and handling of components.