Drug factory · FDA FEI 3011034132

Smith & Nephew Wound Management

4900 W Vickery Blvd, Fort Worth, TX, United States

Serious problems, FDA action at FDA's last inspection, Feb 26, 2026.

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

2 drug inspections on record since 2018: 1 with no problems, 0 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Collagenase Clostridium Histolyticum	Tests it	Smith & Nephew, Inc	50484-010

Ended	Result	Program	Problems noted
Feb 26, 2026	Serious problems, FDA action	Drug Quality Assurance	3
Jun 29, 2018	No problems found	Drug Quality Assurance	—

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

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.
Components withheld from use pending release 21 CFR 211.84(a)
Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

Registered with FDA for: analysis; manufacture.