AbbVie Biotechnology LTD
Form 483 issued October 30, 2023 · Barceloneta, Puerto Rico
- Inspection
- Oct 17 – Oct 30, 2023
- Observations
- 1
- Pages
- 2
- FEI number
- 3004620772
In short: On October 30, 2023, FDA issued a Form 483 with 1 observation to AbbVie Biotechnology LTD in Barceloneta, Puerto Rico (FEI 3004620772) after an inspection that ran Oct 17 – Oct 30, 2023. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
This inspection in context
Questions about this 483
What did FDA find at AbbVie Biotechnology LTD?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was AbbVie Biotechnology LTD inspected by FDA?
The inspection ran Oct 17 – Oct 30, 2023, and the Form 483 is dated October 30, 2023.
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.