Boehringer Ingelheim Fremont, Inc.
Form 483 issued November 4, 2022 · Fremont, California
- Inspection
- Oct 25 – Nov 4, 2022
- Investigators
- Christopher R. Czajka· Jeffrey P. Raimondi
- Observations
- 1
- Pages
- 4
- FEI number
- 3005925062
In short: On November 4, 2022, FDA issued a Form 483 with 1 observation to Boehringer Ingelheim Fremont, Inc. in Fremont, California (FEI 3005925062) after an inspection that ran Oct 25 – Nov 4, 2022. The investigators were Christopher R. Czajka and Jeffrey P. Raimondi. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmBoehringer Ingelheim Fremont, 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boehringer Ingelheim Fremont, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. 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 Boehringer Ingelheim Fremont, Inc.?
Christopher R. Czajka and Jeffrey P. Raimondi are named on this Form 483, for the inspection of Oct 25 – Nov 4, 2022. Each investigator has a profile showing what they cite most.
When was Boehringer Ingelheim Fremont, Inc. inspected by FDA?
The inspection ran Oct 25 – Nov 4, 2022, and the Form 483 is dated November 4, 2022.
How do I get the full Form 483 for Boehringer Ingelheim Fremont, Inc.?
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