Form 483 · FEI 3018521591
Form 483 issued March 18, 2025 · Glendale, California
- Inspection
- Mar 17 – Mar 18, 2025
- Investigator
- Jeffrey P. Raimondi
- Observations
- 4
- Pages
- 4
- FEI number
- 3018521591
In short: On March 18, 2025, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Glendale, California (FEI 3018521591) after an inspection that ran Mar 17 – Mar 18, 2025. The investigator was Jeffrey P. Raimondi. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 02
Written records are not always made of…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and quality system. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Jeffrey P. Raimondi is named on this Form 483, for the inspection of Mar 17 – Mar 18, 2025. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Mar 17 – Mar 18, 2025, and the Form 483 is dated March 18, 2025.
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.