Pegasus Research Corporation
Form 483 issued April 7, 2021 · Santa Ana, California
- Investigator
- Kevin N. Tran
- Observations
- 1
- Pages
- 3
In short: On April 7, 2021, FDA issued a Form 483 with 1 observation to Pegasus Research Corporation in Santa Ana, California. The investigator was Kevin N. Tran. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design control have not been established. Procedures for design control have…
This inspection in context
Kevin N. Tran
7 documents · 2019–2025
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmPegasus Research Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pegasus Research Corporation?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Pegasus Research Corporation?
Kevin N. Tran is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Pegasus Research Corporation inspected by FDA?
This Form 483 is dated April 7, 2021.
How do I get the full Form 483 for Pegasus Research Corporation?
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