Bachem Americas, Inc.
Form 483 issued December 13, 2019 · Torrance, California
- Observations
- 3
- Pages
- 2
- FEI number
- 2024023
In short: On December 13, 2019, FDA issued a Form 483 with 3 observations to Bachem Americas, Inc. in Torrance, California (FEI 2024023). Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Master Batch Production and batch production and control records…
- 02
Evaluation of potential contamination of the purified water system and tools used for API production is…
- 03
Contract Laboratory Qualification is…
This inspection in context
Questions about this 483
What did FDA find at Bachem Americas, Inc.?
FDA listed 3 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
When was Bachem Americas, Inc. inspected by FDA?
This Form 483 is dated December 13, 2019.
How do I get the full Form 483 for Bachem Americas, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.