Boehringer Ingelheim Animal Health Puerto Rico LLC
Form 483 issued March 29, 2019 · Barceloneta, Puerto Rico
- Inspection
- Mar 20 – Mar 29, 2019
- Investigator
- Marian E. Ramirez
- Observations
- 1
- Pages
- 3
- FEI number
- 2623436
In short: On March 29, 2019, FDA issued a Form 483 with 1 observation to Boehringer Ingelheim Animal Health Puerto Rico LLC in Barceloneta, Puerto Rico (FEI 2623436) after an inspection that ran Mar 20 – Mar 29, 2019. The investigator was Marian E. Ramirez. 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 observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Marian E. Ramirez
20 documents · 2016–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBoehringer Ingelheim Animal Health Puerto Rico LLC history
The site's inspection history, in date order.
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 Boehringer Ingelheim Animal Health Puerto Rico LLC?
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 Boehringer Ingelheim Animal Health Puerto Rico LLC?
Marian E. Ramirez is named on this Form 483, for the inspection of Mar 20 – Mar 29, 2019. Each investigator has a profile showing what they cite most.
When was Boehringer Ingelheim Animal Health Puerto Rico LLC inspected by FDA?
The inspection ran Mar 20 – Mar 29, 2019, and the Form 483 is dated March 29, 2019.
How do I get the full Form 483 for Boehringer Ingelheim Animal Health Puerto Rico LLC?
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