Inspection Record

Enemeez LLC — FDA 483 Findings

US FDAInspected 2026-02-12Published 2026-07-13 4 findingsProcess validationLaboratory and QC controlsMaterial and supplier controlQuality unit oversight

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

Findings

1Process validation

Control procedures are not established which 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.

2Laboratory and QC controls

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.

3Material and supplier control

Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

4Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

About this record

Extracted automatically from the document US FDA published on 2026-07-13. 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.

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