Inspection Record

Leiter’s Enterprises, Inc. — FDA 483 Findings

US FDAInspected 2018-12-19Published 2019-04-30 3 findingsTraining and personnelAseptic processing and sterility assuranceQuality unit oversight

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

1Training and personnel

Employees engaged in the processing of a chug product lack the training required to perfo1m their assigned functions.

2Aseptic processing and sterility assurance

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

3Quality unit oversight

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

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. findings history — including this company's other documentsAll US FDA findings US FDA documents, 2019 Go to Findings search
Weekly Newsletter

Get new findings like these every Monday

Every Monday we email the week's new findings and actions from the FDA, EMA, Health Canada and MFDS. Each one links to its record on our site, where you'll find the regulator's original document. We'll also let you know when the site gains new features. Unsubscribe any time with one click.

See recent findings first

Sent every Monday · a confirmation email follows when you subscribe · unsubscribe from the footer of any email.