FDA Form 483 Fenwal International Inc. Bajos De Haina, Dominican Republic April 2023

Form 483 issued April 25, 2023

Inspection: Apr 17 – Apr 25, 2023
Investigator: Creighton T. Tuzon
Observations: 7
Pages: 8

In short: On April 25, 2023, FDA issued a Form 483 with 7 observations to FDA Form 483 Fenwal International Inc. Bajos De Haina, Dominican Republic April 2023 after an inspection that ran Apr 17 – Apr 25, 2023. The investigator was Creighton T. Tuzon.

What FDA observed

Preview: the opening words of each observation

01
Products that do not conform to specifications…
02
Observation 2: scanned text, readable in the full document.
03
Buildings are not of suitable design…
04
Procedmes to control environmental conditions…

3 more observations

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

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This inspection in context

The investigator

Creighton T. Tuzon

6 documents · 2020–2025

Cites 1271.47 (what procedures must i establish and maintain?) more than any other section. Most of their documents are for sites in California.

The firm

FDA Form 483 Fenwal International Inc. Bajos De Haina, Dominican Republic April 2023 history

The site's inspection history, in date order.

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FDA Form 483 Fenwal International Inc. Bajos De Haina, Dominican Republic April 2023 site file

Every document for this site, in date order, with what was cited at each inspection.

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Questions about this 483

What did FDA find at FDA Form 483 Fenwal International Inc. Bajos De Haina, Dominican Republic April 2023?

FDA listed 7 observations on this Form 483. The opening words of each observation are shown on this page.

Who inspected FDA Form 483 Fenwal International Inc. Bajos De Haina, Dominican Republic April 2023?

Creighton T. Tuzon is named on this Form 483, for the inspection of Apr 17 – Apr 25, 2023. Each investigator has a profile showing what they cite most.

When was FDA Form 483 Fenwal International Inc. Bajos De Haina, Dominican Republic April 2023 inspected by FDA?

The inspection ran Apr 17 – Apr 25, 2023, and the Form 483 is dated April 25, 2023.

How do I get the full Form 483 for FDA Form 483 Fenwal International Inc. Bajos De Haina, Dominican Republic April 2023?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.