DIAGAST
Form 483 issued April 19, 2024
- Inspection
- Apr 11 – Apr 19, 2024
- Investigators
- Creighton T. Tuzon· Richard T. Riggie
- Observations
- 6
- Pages
- 9
- FEI number
- 3006261638
In short: On April 19, 2024, FDA issued a Form 483 with 6 observations to DIAGAST (FEI 3006261638) after an inspection that ran Apr 11 – Apr 19, 2024. The investigators were Creighton T. Tuzon and Richard T. Riggie.
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Failure to submit a…
- 03
Risk analysis is inadequate…
- 04
Procedures for the control of storage areas and stock rooms have…
This inspection in context
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 firmDIAGAST history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at DIAGAST?
FDA listed 6 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected DIAGAST?
Creighton T. Tuzon and Richard T. Riggie are named on this Form 483, for the inspection of Apr 11 – Apr 19, 2024. Each investigator has a profile showing what they cite most.
When was DIAGAST inspected by FDA?
The inspection ran Apr 11 – Apr 19, 2024, and the Form 483 is dated April 19, 2024.
How do I get the full Form 483 for DIAGAST?
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.