Emergent Biodefense Operations Lansing LLC

Form 483 issued October 26, 2000 · Lansing, Michigan

Inspection: Oct 10 – Oct 26, 2000
Observations: 24
Pages: 18
FEI number: 1873886

In short: On October 26, 2000, FDA issued a Form 483 with 24 observations to Emergent Biodefense Operations Lansing LLC in Lansing, Michigan (FEI 1873886) after an inspection that ran Oct 10 – Oct 26, 2000. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

Observations span 4 systems, led by quality system.

Quality system5

Facilities & equipment4

Production4

Biologics CGMP4

Other7

Most cited: 21 CFR 211.192 (5×) · 211.113 (4×)

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 211.42 21 CFR 600.11
The design and construction of the filling suite (Rms a environmental monitoring, cleaning, and employee practices…
02
21 CFR 211.42 21 CFR 211.113
The gowning room for filling Building ®, Room@i) has airlock…
03
21 CFR 211.113
There is no assurance that environmental samples taken in the filling suite in Building @® Room…
04
one solution is used for cleaning surfaces including the curtain, floor, walls, ceiling and oven and…

20 more observations

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

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This inspection in context

The firm

Emergent Biodefense Operations Lansing LLC history

All 11 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

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Questions about this 483

What did FDA find at Emergent Biodefense Operations Lansing LLC?

FDA listed 24 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.

When was Emergent Biodefense Operations Lansing LLC inspected by FDA?

The inspection ran Oct 10 – Oct 26, 2000, and the Form 483 is dated October 26, 2000.

How do I get the full Form 483 for Emergent Biodefense Operations Lansing LLC?

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