FDA Intel

CRODA IBERICA SA

Form 483 issued August 8, 2019 · Barcelona, Spain

Observations
3
Pages
2
FEI number
3007494492

In short: On August 8, 2019, FDA issued a Form 483 with 3 observations to CRODA IBERICA SA in Barcelona, Spain (FEI 3007494492). Most observations concern quality system and laboratory controls.

At a glance

2 of 3 observations on this 483 concern quality system.

Quality system2
Laboratory controls1

What FDA observed

Preview: the opening words of each observation

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

  1. 01
    21 CFR 211.166

    Failure to store stability samples in containers simulating containers…

  2. 02
    21 CFR 211.22

    Failure of your quality unit to ensure that…

  3. 03
    21 CFR 211.25

    Failure to ensure training is regularly conducted by qualified individuals and covers, at a minimum, the…

The full 483

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

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This inspection in context

The firm

CRODA IBERICA SA history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.166

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Questions about this 483

What did FDA find at CRODA IBERICA SA?

FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.

When was CRODA IBERICA SA inspected by FDA?

This Form 483 is dated August 8, 2019.

How do I get the full Form 483 for CRODA IBERICA SA?

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