AbbVie Bioresearch Center
Form 483 issued December 7, 2012 · Worcester, Massachusetts
- Inspection
- Sep 9 – Dec 7, 2012
- Investigators
- Junho Pak· Qing Zhou· Reyes Candau-Chacon
- Observations
- 1
- Pages
- 1
- FEI number
- 3003684386
In short: On December 7, 2012, FDA issued a Form 483 with 1 observation to AbbVie Bioresearch Center in Worcester, Massachusetts (FEI 3003684386) after an inspection that ran Sep 9 – Dec 7, 2012. The investigators were Junho Pak, Qing Zhou and Reyes Candau-Chacon. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Microbiology methods are not…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmAbbVie Bioresearch Center history
The site's inspection history, in date order.
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 Bioresearch Center?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. 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 Bioresearch Center?
Junho Pak, Qing Zhou and Reyes Candau-Chacon are named on this Form 483, for the inspection of Sep 9 – Dec 7, 2012. Each investigator has a profile showing what they cite most.
When was AbbVie Bioresearch Center inspected by FDA?
The inspection ran Sep 9 – Dec 7, 2012, and the Form 483 is dated December 7, 2012.
How do I get the full Form 483 for AbbVie Bioresearch Center?
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.