Bachem Americas, Inc.
Form 483 issued March 27, 2023 · Vista, California
- Inspection
- Mar 20 – Mar 27, 2023
- Investigator
- Cecilia H. Kieu
- Observations
- 4
- Pages
- 6
- FEI number
- 3000718309
In short: On March 27, 2023, FDA issued a Form 483 with 4 observations to Bachem Americas, Inc. in Vista, California (FEI 3000718309) after an inspection that ran Mar 20 – Mar 27, 2023. The investigator was Cecilia H. Kieu. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is evidence of a failure of your quality unit to exercise its responsibility to ensure…
- 02
There is a failure to have a quality unit that is independent of production, and fulfills…
- 03
There is evidence of a failure to ensure training is regularly conducted by qualified individuals and…
- 04
Your firm failed to properly maintain buildings and facilities used in the manufacture of intermediates and…
This inspection in context
Cecilia H. Kieu
13 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmBachem Americas, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bachem Americas, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Bachem Americas, Inc.?
Cecilia H. Kieu is named on this Form 483, for the inspection of Mar 20 – Mar 27, 2023. Each investigator has a profile showing what they cite most.
When was Bachem Americas, Inc. inspected by FDA?
The inspection ran Mar 20 – Mar 27, 2023, and the Form 483 is dated March 27, 2023.
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.