Form 483 · FEI 3007208829
Form 483 issued July 31, 2024 · San Francisco, California
- Inspection
- Jul 15 – Jul 31, 2024
- Investigators
- Katelyn A. Staub-Zamperini· Kenya Destin
- Observations
- 3
- Pages
- 9
- FEI number
- 3007208829
In short: On July 31, 2024, FDA issued a Form 483 with 3 observations to an FDA-inspected site in San Francisco, California (FEI 3007208829) after an inspection that ran Jul 15 – Jul 31, 2024. The investigators were Katelyn A. Staub-Zamperini and Kenya Destin. Most observations concern cAPA and design controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.100(a)21 CFR 803
Procedures for corrective and preventive action have…
- 02
Risk analysis is…
- 03
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Katelyn A. Staub-Zamperini
7 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Katelyn A. Staub-Zamperini and Kenya Destin are named on this Form 483, for the inspection of Jul 15 – Jul 31, 2024. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 15 – Jul 31, 2024, and the Form 483 is dated July 31, 2024.
How do I get the full Form 483 for an FDA-inspected site?
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.