AbbVie Biotechnology LTD
Form 483 issued March 25, 2019 · Barceloneta, Puerto Rico
- Inspection
- Mar 12 – Mar 25, 2019
- Investigator
- Libia M. Lugo
- Observations
- 3
- Pages
- 11
- FEI number
- 3004620772
In short: On March 25, 2019, FDA issued a Form 483 with 3 observations to AbbVie Biotechnology LTD in Barceloneta, Puerto Rico (FEI 3004620772) after an inspection that ran Mar 12 – Mar 25, 2019. The investigator was Libia M. Lugo. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output of those manufacturing processes that nay be…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 03
Written records of investigation of a drug…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) 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 211.110(a)
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 production. The opening words of each observation are shown on this page.
Who inspected AbbVie Biotechnology LTD?
Libia M. Lugo is named on this Form 483, for the inspection of Mar 12 – Mar 25, 2019. Each investigator has a profile showing what they cite most.
When was AbbVie Biotechnology LTD inspected by FDA?
The inspection ran Mar 12 – Mar 25, 2019, and the Form 483 is dated March 25, 2019.
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.