Bachem Americas, Inc.February 10, 2017

FDA 483 - Bachem Americas, Inc. - February 10, 2017

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 Bachem Americas, Inc.

Record Details

An FDA inspection of Bachem Americas, Inc. in Vista, CA, revealed two significant observations. The firm failed to implement appropriate controls over computer systems, specifically a titrator used for API moisture content, lacking validation and unauthorized data control. Additionally, a leaking plumbing system was observed near the manufacturing area, posing a contamination risk to drug products.

Company: Bachem Americas, Inc.
Inspection Date: February 10, 2017
Product Type: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Walden H. Lee (Chemist/Investigator - Pharmaceutical Quality)
Santos E. Camara

Open in Dashboard

ID · 7ccbb52d-8066-427b-b84f-7cfe2e5b0e78