Rolenn Manufacturing Inc
Form 483 issued December 5, 2024 · Riverside, California
- Inspection
- Dec 3 – Dec 5, 2024
- Investigator
- Linda Galindo
- Observations
- 2
- Pages
- 3
In short: On December 5, 2024, FDA issued a Form 483 with 2 observations to Rolenn Manufacturing Inc in Riverside, California after an inspection that ran Dec 3 – Dec 5, 2024. The investigator was Linda Galindo. 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 (1×) · 820.75 (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 finished device acceptance have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Linda Galindo
4 documents · 2024–2026
Cites 820.80 (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in California.
The firmRolenn Manufacturing Inc 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 Rolenn Manufacturing Inc?
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 Rolenn Manufacturing Inc?
Linda Galindo is named on this Form 483, for the inspection of Dec 3 – Dec 5, 2024. Each investigator has a profile showing what they cite most.
When was Rolenn Manufacturing Inc inspected by FDA?
The inspection ran Dec 3 – Dec 5, 2024, and the Form 483 is dated December 5, 2024.
How do I get the full Form 483 for Rolenn Manufacturing Inc?
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.