AbbVie Biotechnology LTD
Form 483 issued April 28, 2017 · Barceloneta, Puerto Rico
- Inspection
- Apr 19 – Apr 28, 2017
- Investigator
- Noreen Muniz
- Observations
- 3
- Pages
- 4
- FEI number
- 3004620772
In short: On April 28, 2017, FDA issued a Form 483 with 3 observations to AbbVie Biotechnology LTD in Barceloneta, Puerto Rico (FEI 3004620772) after an inspection that ran Apr 19 – Apr 28, 2017. The investigator was Noreen Muniz. Most observations concern quality system and materials.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Procedures for the inspection and tests of materials used as components (raw materials and syringes) in…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmAbbVie Biotechnology LTD history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AbbVie Biotechnology LTD?
FDA listed 3 observations on this Form 483, mostly about quality system and materials. The opening words of each observation are shown on this page.
Who inspected AbbVie Biotechnology LTD?
Noreen Muniz is named on this Form 483, for the inspection of Apr 19 – Apr 28, 2017. Each investigator has a profile showing what they cite most.
When was AbbVie Biotechnology LTD inspected by FDA?
The inspection ran Apr 19 – Apr 28, 2017, and the Form 483 is dated April 28, 2017.
How do I get the full Form 483 for AbbVie Biotechnology LTD?
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.