Alexion Pharmaceuticals, Inc.
Form 483 issued August 3, 2016 · Smithfield, Rhode Island
- Inspection
- Aug 3, 2016
- Investigators
- Edmund F. Mrak Jr· Nealie C. Newberger
- Observations
- 3
- Pages
- 2
- FEI number
- 3006568549
In short: On August 3, 2016, FDA issued a Form 483 with 3 observations to Alexion Pharmaceuticals, Inc. in Smithfield, Rhode Island (FEI 3006568549) after an inspection that ran Aug 3, 2016. The investigators were Edmund F. Mrak Jr and Nealie C. Newberger. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations are not always complete in that Eculizumab Bulk Drug Substance was released before the satisfactory…
- 02
Surface sampling methods have not been validated to provide results meaningful to your environmental monitoring program…
- 03
You do not have bioburden and endotoxin data to support the use o: [is an ingredient…
This inspection in context
Edmund F. Mrak Jr
7 documents · 2012–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Massachusetts.
The firmAlexion Pharmaceuticals, Inc. history
All 5 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 Alexion Pharmaceuticals, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Alexion Pharmaceuticals, Inc.?
Edmund F. Mrak Jr and Nealie C. Newberger are named on this Form 483, for the inspection of Aug 3, 2016. Each investigator has a profile showing what they cite most.
When was Alexion Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Aug 3, 2016, and the Form 483 is dated August 3, 2016.
How do I get the full Form 483 for Alexion Pharmaceuticals, 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.