Bajaj Medical, LLC

Form 483 issued December 4, 2024 · Chicago, Illinois

Observations: 1
Pages: 2
FEI number: 3010164083

In short: On December 4, 2024, FDA issued a Form 483 with 1 observation to Bajaj Medical, LLC in Chicago, Illinois (FEI 3010164083). 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

01
21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt and evaluation of post…

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The firm

Bajaj Medical, LLC history

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Questions about this 483

What did FDA find at Bajaj Medical, LLC?

FDA listed 1 observation 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 Bajaj Medical, LLC inspected by FDA?

This Form 483 is dated December 4, 2024.

How do I get the full Form 483 for Bajaj Medical, LLC?

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