FDA Form 483 FUJINOMIYA FACTORY OF TERUMO CORP Fujinomiya, Japan May 2023
Form 483 issued May 19, 2023 · Fujinomiya, Japan
- Inspection
- May 15 – May 19, 2023
- Investigator
- Irina Gaberman
- Observations
- 6
- Pages
- 5
In short: On May 19, 2023, FDA issued a Form 483 with 6 observations to FDA Form 483 FUJINOMIYA FACTORY OF TERUMO CORP Fujinomiya, Japan May 2023 in Fujinomiya, Shizuoka after an inspection that ran May 15 – May 19, 2023. The investigator was Irina Gaberman.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Written procedures are not followed for the testing and approval…
- 03
Failure to maintain a backup file of data entered into the…
- 04
Records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems are…
This inspection in context
Irina Gaberman
8 documents · 2011–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmFDA Form 483 FUJINOMIYA FACTORY OF TERUMO CORP Fujinomiya, Japan May 2023 history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at FDA Form 483 FUJINOMIYA FACTORY OF TERUMO CORP Fujinomiya, Japan May 2023?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected FDA Form 483 FUJINOMIYA FACTORY OF TERUMO CORP Fujinomiya, Japan May 2023?
Irina Gaberman is named on this Form 483, for the inspection of May 15 – May 19, 2023. Each investigator has a profile showing what they cite most.
When was FDA Form 483 FUJINOMIYA FACTORY OF TERUMO CORP Fujinomiya, Japan May 2023 inspected by FDA?
The inspection ran May 15 – May 19, 2023, and the Form 483 is dated May 19, 2023.
How do I get the full Form 483 for FDA Form 483 FUJINOMIYA FACTORY OF TERUMO CORP Fujinomiya, Japan May 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.