Rolenn Manufacturing Inc

FDA inspection history in Riverside, California, 2024

1
Form 483

Every document, by year

  • Form 483

2024: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2024One Form 483, at Riverside, California.

Cited most

Across all Rolenn Manufacturing observations on file

The complete Rolenn Manufacturing file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2024-12-05483 Form 483$99

Investigators on these documents

Linda Galindo (1)

About Rolenn Manufacturing Inc

How many FDA Form 483s has Rolenn Manufacturing Inc received?

FDA Intel has 1 Form 483 on file for Rolenn Manufacturing Inc; the most recent is dated Dec 5, 2024.

When was Rolenn Manufacturing Inc last inspected by FDA?

The most recent FDA inspection document on file for Rolenn Manufacturing Inc is a Form 483 dated Dec 5, 2024, for the site in Riverside, California.

What did FDA cite at Rolenn Manufacturing Inc?

The regulations cited most in the observations on file for Rolenn Manufacturing Inc are 21 CFR 820.75 (Process validation), 1 time; 21 CFR 820.80 (Receiving, in-process, and finished device acceptance), 1 time.