Biogen Idec Inc.
Form 483 issued August 2, 2013 · RTP, North Carolina
- Inspection
- Jul 29 – Aug 2, 2013
- Investigators
- Jose A. Cruz-Gonzalez· Seneca Toms
- Observations
- 2
- Pages
- 2
- FEI number
- 3000719749
In short: On August 2, 2013, FDA issued a Form 483 with 2 observations to Biogen Idec Inc. in RTP, North Carolina (FEI 3000719749) after an inspection that ran Jul 29 – Aug 2, 2013. The investigators were Jose A. Cruz-Gonzalez and Seneca Toms. Most observations concern materials and quality system.
At a glance
Materials and quality system account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no assurance that the firm always challenges the validity of all testing results provided…
- 02
The firm fails to adequately and/or completely document, in equipment logbooks and/or in production records, the…
This inspection in context
Jose A. Cruz-Gonzalez
11 documents · 2013–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBiogen Idec Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biogen Idec Inc.?
FDA listed 2 observations on this Form 483, mostly about materials and quality system. The opening words of each observation are shown on this page.
Who inspected Biogen Idec Inc.?
Jose A. Cruz-Gonzalez and Seneca Toms are named on this Form 483, for the inspection of Jul 29 – Aug 2, 2013. Each investigator has a profile showing what they cite most.
When was Biogen Idec Inc. inspected by FDA?
The inspection ran Jul 29 – Aug 2, 2013, and the Form 483 is dated August 2, 2013.
How do I get the full Form 483 for Biogen Idec Inc.?
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.