Inspection Record

LeeSar, Inc. — FDA 483 Findings

US FDAInspected 2025-05-09Published 2025-06-23 4 findingsDeviation, CAPA, and investigationQuality unit oversightProcess validation

Inspectors Kayla V SpragueThe inspectors who signed the published document.Inspector lookup

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

Findings

1Deviation, CAPA, and investigation

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.

2Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not in writing and folly followed.

3Process validation

Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

4Quality unit oversight

Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.

About this record

Extracted automatically from the document US FDA published on 2025-06-23. 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.

Other records for this company

2018-01-16 · US FDA · 6 findings2018-10-24 · US FDA · 4 findings2021-10-29 · US FDA · 5 findings
LeeSar, Inc. company profile — full history US FDA documents, 2025 Go to Findings search