Inspection Record

Turbare Manufacturing — FDA 483 Findings

US FDAInspected 2026-07-07Published 2026-07-14 4 findingsDeviation, CAPA, and investigationAseptic processing and sterility assuranceQuality unit oversightTraining and personnel

Inspectors Sangeeta M. KhuranaThe 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.

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

3Quality unit oversight

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

4Training and personnel

Production personnel were not practicing good sanitation and health habits.

About this record

Extracted automatically from the document US FDA published on 2026-07-14. 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

2025-12-02 · US FDA · 9 findings2025-01-24 · US FDA · 8 findings
Turbare Manufacturing company profile — full history US FDA documents, 2026 Go to Findings search