Inspection Record

Allure Labs, LLC — FDA 483 Findings

US FDAInspected 2026-03-27Published 2026-07-15 3 findingsMaterial and supplier controlLaboratory and QC controlsComputer system validation

View the regulator's official source The source document is always the basis for judgement.

Findings

1Material and supplier control

There is a failure to thoroughly review 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.

2Laboratory and QC controls

The accuracy of test methods have not been established.

3Computer system validation

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.

About this record

Extracted automatically from the document US FDA published on 2026-07-15. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Allure Labs, LLC company profile — full history US FDA documents, 2026 Go to Findings search