Solevy Co. LLC
Form 483 issued February 12, 2024 · Santa Clarita, California
- Inspection
- Feb 7 – Feb 12, 2024
- Observations
- 2
- Pages
- 2
- FEI number
- 3016842367
In short: On February 12, 2024, FDA issued a Form 483 with 2 observations to Solevy Co. LLC in Santa Clarita, California (FEI 3016842367) after an inspection that ran Feb 7 – Feb 12, 2024. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 1 system, led by design controls.
Most cited: 21 CFR 830 (1×) · 820.30(e) (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 830
The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet…
- 02
The design review results, including identification of the design, the date and the individual(s) performing the…
This inspection in context
Questions about this 483
What did FDA find at Solevy Co. LLC?
FDA listed 2 observations 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.
When was Solevy Co. LLC inspected by FDA?
The inspection ran Feb 7 – Feb 12, 2024, and the Form 483 is dated February 12, 2024.
How do I get the full Form 483 for Solevy Co. LLC?
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