Form 483, May 12, 2023
Form 483 issued May 12, 2023
- Inspection
- May 8 – May 12, 2023
- Investigators
- Brandon L. Mariner· Irina Gaberman
- Observations
- 2
- Pages
- 4
In short: On May 12, 2023, FDA issued a Form 483 with 2 observations to an FDA-inspected site after an inspection that ran May 8 – May 12, 2023. The investigators were Brandon L. Mariner and Irina Gaberman. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Acceptance activities were not…
- 02
Procedures for acceptance of incoming product have…
This inspection in context
Brandon L. Mariner
1 document · 2023
Cites 820.80 (receiving, in-process, and finished device acceptance) more than any other section.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Brandon L. Mariner and Irina Gaberman are named on this Form 483, for the inspection of May 8 – May 12, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran May 8 – May 12, 2023, and the Form 483 is dated May 12, 2023.
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.