Patheon Puerto Rico, Inc.October 15, 2019

FDA 483 - Patheon Puerto Rico, Inc. - October 15, 2019

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Patheon Puerto Rico, Inc.

Record Details

Patheon part of Thermo Fisher in Manati, PR, was inspected from October 1-15, 2019, and received a Form 483 with two observations. The firm failed to thoroughly review unexplained discrepancies related to Levothyroxine Sodium Tablets and did not follow established production and process control procedures for Janumet Tablets. These issues indicate deficiencies in quality system and production control functions.

Company: Patheon Puerto Rico, Inc.
Inspection Date: October 15, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East IV
People: Jose R Flores-Veguilla
Jose F. Velez

Open in Dashboard

ID · c394fc2c-18ad-4917-b21e-8a0d16fe1773