AbbVie Biotechnology LTD
Form 483 issued March 24, 2016 · Barceloneta, Puerto Rico
- Inspection
- Mar 14 – Mar 24, 2016
- Investigators
- Ivis L. Negron· Noreen Muniz
- Observations
- 8
- Pages
- 5
- FEI number
- 3004620772
In short: On March 24, 2016, FDA issued a Form 483 with 8 observations to AbbVie Biotechnology LTD in Barceloneta, Puerto Rico (FEI 3004620772) after an inspection that ran Mar 14 – Mar 24, 2016. The investigators were Ivis L. Negron and Noreen Muniz. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 7 of 8 observations.
Most cited: 21 CFR 211.160 (3×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of manufacturing deviations documented on site in accordance with approved procedure (b) (4) , Nonconformity…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Procedure (b) (4) , Management Review, approved for site execution of operations Management Review Meetings on…
- 04
Trend review records executed as described in SOP. (b) (4) Environmental Monitoring Trend Evaluation, approved on…
This inspection in context
Ivis L. Negron
2 documents · 2001–2016
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AbbVie Biotechnology LTD?
FDA listed 8 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected AbbVie Biotechnology LTD?
Ivis L. Negron and Noreen Muniz are named on this Form 483, for the inspection of Mar 14 – Mar 24, 2016. Each investigator has a profile showing what they cite most.
When was AbbVie Biotechnology LTD inspected by FDA?
The inspection ran Mar 14 – Mar 24, 2016, and the Form 483 is dated March 24, 2016.
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.