Bachem Americas, Inc.
Form 483 issued June 12, 2019 · Torrance, California
- Inspection
- Jun 3 – Jun 12, 2019
- Investigator
- Bryan A. Galvez
- Observations
- 1
- Pages
- 1
- FEI number
- 2024023
In short: On June 12, 2019, FDA issued a Form 483 with 1 observation to Bachem Americas, Inc. in Torrance, California (FEI 2024023) after an inspection that ran Jun 3 – Jun 12, 2019. The investigator was Bryan A. Galvez. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm did not adequately determine the cause of out of…
This inspection in context
Bryan A. Galvez
15 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmBachem Americas, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bachem Americas, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Bachem Americas, Inc.?
Bryan A. Galvez is named on this Form 483, for the inspection of Jun 3 – Jun 12, 2019. Each investigator has a profile showing what they cite most.
When was Bachem Americas, Inc. inspected by FDA?
The inspection ran Jun 3 – Jun 12, 2019, and the Form 483 is dated June 12, 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.