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BRACCO DIAGNOSTICS INC

Form 483 issued November 27, 2024 · Princeton, New Jersey

Inspection
Nov 27, 2024
Observations
2
Pages
4
FEI number
1000307800

In short: On November 27, 2024, FDA issued a Form 483 with 2 observations to BRACCO DIAGNOSTICS INC in Princeton, New Jersey (FEI 1000307800) after an inspection that ran Nov 27, 2024. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 314.80(c)(1)(i)

    Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…

  2. 02
    21 CFR 314.80(b)

    Written procedures have not been developed for the reporting to FDA of post…

The full 483

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This inspection in context

The firm

BRACCO DIAGNOSTICS INC history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

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Other sites cited under 314.80(c)(1)(i)

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Questions about this 483

What did FDA find at BRACCO DIAGNOSTICS INC?

FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.

When was BRACCO DIAGNOSTICS INC inspected by FDA?

The inspection ran Nov 27, 2024, and the Form 483 is dated November 27, 2024.

How do I get the full Form 483 for BRACCO DIAGNOSTICS INC?

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