Form 483 · FEI 3021769057
Form 483 issued July 31, 2024 · Cypress, California
- Inspection
- Jul 15 – Jul 31, 2024
- Investigators
- James R. Montero· Katlin N. Stubbs
- Observations
- 3
- Pages
- 8
- FEI number
- 3021769057
In short: On July 31, 2024, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Cypress, California (FEI 3021769057) after an inspection that ran Jul 15 – Jul 31, 2024. The investigators were James R. Montero and Katlin N. Stubbs. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
CAPA and production & process controls account for 2 of 3 observations.
Most cited: 21 CFR 820.198 (1×) · 820.250 (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 receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 03
Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process…
This inspection in context
James R. Montero
10 documents · 2014–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmSite history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
James R. Montero and Katlin N. Stubbs are named on this Form 483, for the inspection of Jul 15 – Jul 31, 2024. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 15 – Jul 31, 2024, and the Form 483 is dated July 31, 2024.
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.