Form 483 · FEI 3021769057
Form 483 issued August 12, 2022 · Cypress, California
- Inspection
- Aug 12, 2022
- Investigators
- Alexandria L. Capuano· Janet Pulver
- Observations
- 4
- Pages
- 8
- FEI number
- 3021769057
In short: On August 12, 2022, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Cypress, California (FEI 3021769057) after an inspection that ran Aug 12, 2022. The investigators were Alexandria L. Capuano and Janet Pulver. Most observations concern cAPA and production & process controls.
At a glance
3 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Alexandria L. Capuano
6 documents · 2022–2026
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in California.
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 820.100(a)
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 cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Alexandria L. Capuano and Janet Pulver are named on this Form 483, for the inspection of Aug 12, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Aug 12, 2022, and the Form 483 is dated August 12, 2022.
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.