CENEXI

Form 483 issued July 5, 2013 · OSNY, France

Inspection
Jul 3 – Jul 5, 2013
Observations
1
Pages
2
FEI number
3008138971

In short: On July 5, 2013, FDA issued a Form 483 with 1 observation to CENEXI in OSNY, France (FEI 3008138971) after an inspection that ran Jul 3 – Jul 5, 2013. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

1 of 1 observations on this 483 concern facilities & equipment.

Facilities & equipment1

Most cited: 21 CFR 211.67 (1×)

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Cleaning Validation of the (b) (4) (b) (4) machine…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at CENEXI?

FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

When was CENEXI inspected by FDA?

The inspection ran Jul 3 – Jul 5, 2013, and the Form 483 is dated July 5, 2013.

How do I get the full Form 483 for CENEXI?

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