Biogen Idec Inc.
Form 483 issued March 23, 2017 · Morrisville, North Carolina
- Inspection
- Mar 23, 2017
- Investigators
- Burnell M. Henry· Susan M. Jackson
- Observations
- 6
- Pages
- 4
- FEI number
- 3000719749
In short: On March 23, 2017, FDA issued a Form 483 with 6 observations to Biogen Idec Inc. in Morrisville, North Carolina (FEI 3000719749) after an inspection that ran Mar 23, 2017. The investigators were Burnell M. Henry and Susan M. Jackson. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 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
Validated computer systems that regulate critical operations are not updated by authorized personnel. ‘A. The Manufacturing…
- 02
Product contamination investigations are…
- 03
Process controls do not ensure adequate tracking of materials in a validated inventory control system, maintains…
- 04
Change controls are not…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
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 211.192
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 quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Biogen Idec Inc.?
Burnell M. Henry and Susan M. Jackson are named on this Form 483, for the inspection of Mar 23, 2017. Each investigator has a profile showing what they cite most.
When was Biogen Idec Inc. inspected by FDA?
The inspection ran Mar 23, 2017, and the Form 483 is dated March 23, 2017.
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.