IPR Pharmaceuticals, Inc.
Form 483 issued June 14, 2018 · Canovanas, Puerto Rico
- Inspection
- Jun 4 – Jun 14, 2018
- Investigator
- Laurimer Kuilan-Torres
- Observations
- 1
- Pages
- 3
- FEI number
- 3003009422
In short: On June 14, 2018, FDA issued a Form 483 with 1 observation to IPR Pharmaceuticals, Inc. in Canovanas, Puerto Rico (FEI 3003009422) after an inspection that ran Jun 4 – Jun 14, 2018. The investigator was Laurimer Kuilan-Torres. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.110(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which of those manufacturing processes that may be responsible for causing…
This inspection in context
Laurimer Kuilan-Torres
16 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmIPR Pharmaceuticals, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at IPR Pharmaceuticals, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected IPR Pharmaceuticals, Inc.?
Laurimer Kuilan-Torres is named on this Form 483, for the inspection of Jun 4 – Jun 14, 2018. Each investigator has a profile showing what they cite most.
When was IPR Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jun 4 – Jun 14, 2018, and the Form 483 is dated June 14, 2018.
How do I get the full Form 483 for IPR Pharmaceuticals, 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.