Alexion Pharmaceuticals, Inc.

Form 483 issued August 6, 2012 · Smithfield, Rhode Island

Inspection: Aug 6, 2012
Investigator: A. Haggerty
Observations: 5
Pages: 4
FEI number: 3006568549

In short: On August 6, 2012, FDA issued a Form 483 with 5 observations to Alexion Pharmaceuticals, Inc. in Smithfield, Rhode Island (FEI 3006568549) after an inspection that ran Aug 6, 2012. The investigator was A. Haggerty. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

3 of 5 observations on this 483 concern quality system.

Quality system3

Facilities & equipment1

Laboratory controls1

Most cited: 21 CFR 211.192 (2×) · 211.22 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.67 21 CFR 211.113
Following a confirmed Bacillus thuringiensis contamination in for Soliris lot- on January 14,2012, a routine CIP…
02
21 CFR 211.192 21 CFR 211.56
Deviation 3324 was initiated due to a leak on the interior of the drywall in a…
03
21 CFR 211.160
The procedure "Quality Conlrol of Microbiological Media" SOP QC-0201, version 5.0 is used for growth promotion…
04
21 CFR 211.192 21 CFR 211.22
Deviations are. not required to be initiated for all visual inspection failures, for ~st…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

A. Haggerty

1 document · 2012

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Rhode Island.

The firm

Alexion Pharmaceuticals, Inc. history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

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Response
The firm's reply to this 483Aug 22, 2012$199

Alexion Pharmaceuticals, Inc. site file

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Questions about this 483

What did FDA find at Alexion Pharmaceuticals, Inc.?

FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. 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 Alexion Pharmaceuticals, Inc.?

A. Haggerty is named on this Form 483, for the inspection of Aug 6, 2012. Each investigator has a profile showing what they cite most.

When was Alexion Pharmaceuticals, Inc. inspected by FDA?

The inspection ran Aug 6, 2012, and the Form 483 is dated August 6, 2012.

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.