Boehringer Ingelheim Fremont, Inc.
Form 483 issued August 24, 2018 · Fremont, California
- Inspection
- Aug 24, 2018
- Investigators
- Anita Narula· Marcus F. Yambot
- Observations
- 5
- Pages
- 6
- FEI number
- 3005925062
In short: On August 24, 2018, FDA issued a Form 483 with 5 observations to Boehringer Ingelheim Fremont, Inc. in Fremont, California (FEI 3005925062) after an inspection that ran Aug 24, 2018. The investigators were Anita Narula and Marcus F. Yambot. Most observations concern production & process controls and laboratory controls.
At a glance
Production & process controls and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration…
- 02
Procedures to ensure equipment is routinely inspected and checked have…
- 03
The written procedures for the stability program for drug substance and drug…
- 04
Failure to properly investigate and…
This inspection in context
Anita Narula
13 documents · 2014–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Oregon.
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 820.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boehringer Ingelheim Fremont, Inc.?
FDA listed 5 observations on this Form 483, mostly about production & process controls, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Boehringer Ingelheim Fremont, Inc.?
Anita Narula and Marcus F. Yambot are named on this Form 483, for the inspection of Aug 24, 2018. Each investigator has a profile showing what they cite most.
When was Boehringer Ingelheim Fremont, Inc. inspected by FDA?
The inspection ran Aug 24, 2018, and the Form 483 is dated August 24, 2018.
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.