Istituto Biochimico Italiano Giovanni Lorenzini

Form 483 issued November 21, 2024 · Aprilia, Italy

Observations
1
Pages
2
FEI number
3002807242

In short: On November 21, 2024, FDA issued a Form 483 with 1 observation to Istituto Biochimico Italiano Giovanni Lorenzini in Aprilia, Latina (FEI 3002807242). The most-cited regulation is 21 CFR 314.81 (other postmarketing reports).

What FDA observed

Preview: the opening words of each observation
  1. 01

    An annual report was not submitted within 60 days of the anniversary date of U.S. approval…

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This inspection in context

Questions about this 483

What did FDA find at Istituto Biochimico Italiano Giovanni Lorenzini?

FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports). The opening words of each observation are shown on this page.

When was Istituto Biochimico Italiano Giovanni Lorenzini inspected by FDA?

This Form 483 is dated November 21, 2024.

How do I get the full Form 483 for Istituto Biochimico Italiano Giovanni Lorenzini?

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