Biogen Idec Inc.
Form 483 issued June 16, 2021 · Morrisville, North Carolina
- Inspection
- Jun 7 – Jun 16, 2021
- Investigators
- Wayne Seifert· Zhao Wang
- Observations
- 6
- Pages
- 5
- FEI number
- 3000719749
In short: On June 16, 2021, FDA issued a Form 483 with 6 observations to Biogen Idec Inc. in Morrisville, North Carolina (FEI 3000719749) after an inspection that ran Jun 7 – Jun 16, 2021. The investigators were Wayne Seifert and Zhao Wang. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and facilities & equipment account for 4 of 6 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 inadequate documentation for training sample sets in Empower and lack of traceability for samples…
- 02
Equipment and facilities are not adequately maintained in Large Scale Manufacturing (LSM) Building} to assure the…
- 03
Recoveries TNTC for the? were obtained from storage in) pending? to) (4) for PPQ 2 (preparation…
- 04
The method validation in the detection of bioburden has not been completed for the to 4)…
This inspection in context
Wayne Seifert
37 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.
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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biogen Idec Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Biogen Idec Inc.?
Wayne Seifert and Zhao Wang are named on this Form 483, for the inspection of Jun 7 – Jun 16, 2021. Each investigator has a profile showing what they cite most.
When was Biogen Idec Inc. inspected by FDA?
The inspection ran Jun 7 – Jun 16, 2021, and the Form 483 is dated June 16, 2021.
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.