Inspection Record

Leiter’s Enterprises, Inc. — FDA 483 Findings

US FDAInspected 2018-12-19Published 2019-04-30 3 findingsQuality unit oversightTraining and personnelAseptic processing and sterility assurance

Inspectors Ashar P ParikhThe inspectors who signed the published document.Inspector lookup

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

Findings

1Quality unit oversight

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

2Training and personnel

Employees engaged in the processing of a drug product lack the training required to perform their assigned functions.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.

About this record

Extracted automatically from the document US FDA published on 2019-04-30. 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

2018-12-19 · US FDA · 3 findings2018-12-19 · US FDA · 3 findings
Leiter’s Enterprises, Inc. company profile — full history US FDA documents, 2019 Go to Findings search