Inspection Record

Sincerus Florida, LLC. — FDA 483 Findings

US FDAInspected 2018-01-08Published 2024-01-17 3 findingsMaterial and supplier controlAseptic processing and sterility assuranceLabeling and packaging

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

Findings

1Material and supplier control

Procedures designed to assure that correct labeling and packaging materials are used for chug products are not written and followed.

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drng products pmp orting to be sterile are not followed.

3Labeling and packaging

The labels of your outsourcing facility's drug products are deficient.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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

2026-05-29 · US FDA · 7 findings2018-09-17 · US FDA · 6 findings
Sincerus Florida, LLC. findings history — including this company's other documentsAll US FDA findings US FDA documents, 2024 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.