Boehringer Ingelheim Fremont, Inc.
Form 483 issued April 4, 2017 · Fremont, California
- Inspection
- Mar 31 – Apr 4, 2017
- Investigators
- Diane Raccasi· Ephrem Hunde· Kristin M. Abaonza
- Observations
- 10
- Pages
- 4
- FEI number
- 3005925062
In short: On April 4, 2017, FDA issued a Form 483 with 10 observations to Boehringer Ingelheim Fremont, Inc. in Fremont, California (FEI 3005925062) after an inspection that ran Mar 31 – Apr 4, 2017. The investigators were Diane Raccasi, Ephrem Hunde, Kristin M. Abaonza, Maria Cruz-Fisher, Monica Commerford, Richard Ledwidge and Tracy Denison. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 8 of 10 observations.
Most cited: 21 CFR 211.160 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do…
- 02
Employees engaged in the manufacturing of a drug product lack the training required to…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
The qualification of critical equipment…
This inspection in context
Diane Raccasi
5 documents · 2015–2019
Cites 211.160 (general requirements) 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boehringer Ingelheim Fremont, Inc.?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Boehringer Ingelheim Fremont, Inc.?
Diane Raccasi, Ephrem Hunde, Kristin M. Abaonza, Maria Cruz-Fisher, Monica Commerford, Richard Ledwidge and Tracy Denison are named on this Form 483, for the inspection of Mar 31 – Apr 4, 2017. Each investigator has a profile showing what they cite most.
When was Boehringer Ingelheim Fremont, Inc. inspected by FDA?
The inspection ran Mar 31 – Apr 4, 2017, and the Form 483 is dated April 4, 2017.
How do I get the full Form 483 for Boehringer Ingelheim Fremont, 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.